U.S. patent number 6,256,523 [Application Number 09/094,202] was granted by the patent office on 2001-07-03 for low-noise optical probes.
This patent grant is currently assigned to Masimo Corporation. Invention is credited to Mohamed Diab, Thomas J. Gerhardt, Esmaiel Kiani-Azarbayjany, Eugene E. Mason, Mike A. Mills, David R. Tobler.
United States Patent |
6,256,523 |
Diab , et al. |
July 3, 2001 |
Low-noise optical probes
Abstract
An optical probe, which is particularly suited to reduce noise
in measurements taken on an easily compressible material, such as a
finger, a toe, a forehead, an earlobe, or a lip, measures
characteristics of the material. A neonatal and adult disposable
embodiment of the probe include adhesive coated surfaces to
securely affix the probe onto the patient. In addition, the surface
of the probe is specially constructed to minimize light piping
effects. Furthermore, a flex circuit acts as a spring to absorb
shock which may misalign the emitter and detector. One embodiment
of the adult probe includes a cushioning pocket formed for a
fingertip to align the probe and to absorb motion of the probe due
to contact. The neonatal probe is formed with a unique
V-configuration which provides multiple advantages.
Inventors: |
Diab; Mohamed (Mission Viejo,
CA), Kiani-Azarbayjany; Esmaiel (Laguna Niguel, CA),
Tobler; David R. (Westminister, CO), Gerhardt; Thomas J.
(Littleton, CO), Mason; Eugene E. (Boulder, CO), Mills;
Mike A. (Golden, CO) |
Assignee: |
Masimo Corporation (Irvine,
CA)
|
Family
ID: |
23301427 |
Appl.
No.: |
09/094,202 |
Filed: |
June 9, 1998 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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543789 |
Oct 16, 1995 |
5782757 |
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333132 |
Nov 1, 1994 |
5638818 |
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672890 |
Mar 21, 1991 |
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Current U.S.
Class: |
600/323;
600/344 |
Current CPC
Class: |
A61B
5/02427 (20130101); A61B 5/14552 (20130101); A61B
5/6826 (20130101); A61B 5/6829 (20130101); A61B
5/6838 (20130101); A61B 2562/08 (20130101); A61B
2562/12 (20130101); H05K 1/189 (20130101); Y10T
29/49826 (20150115) |
Current International
Class: |
A61B
5/024 (20060101); A61B 5/00 (20060101); H05K
1/18 (20060101); A61B 005/00 () |
Field of
Search: |
;600/310,322,323,340,344,473,476 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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89105503 |
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Aug 1983 |
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EP |
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01894 |
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Mar 1992 |
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WO |
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Primary Examiner: Winakur; Eric F.
Attorney, Agent or Firm: Knobbe, Martens, Olson & Bear,
LLP
Parent Case Text
This application is a continuation of U.S. Ser. No. 08/543,789, now
U.S. Pat. No. 5,782,757, filed Oct. 16, 1995, which is a
continuation-in-part of U.S. Ser. No. 08/333,132, filed Nov. 1,
1994, now U.S. Pat. No. 5,638,818 and which is a
continuation-in-part of U.S. Ser. No. 07/672,890, filed Mar. 21,
1991, now abandoned.
Claims
What is claimed is:
1. An optical probe for the non-invasive measurement of
characteristics of a medium, said optical probe comprising:
an emitter which transmits optical radiation;
a detector configured to detect said optical radiation after
attenuation through said medium;
a flexible circuit assembly extending between said emitter and said
detector, said flexible circuit assembly having electrical circuit
paths coupled to said detector and said emitter; and
a cushion positioned between said detector and said emitter along
said flexible circuit, said cushion being formed so that it abuts a
patient's fingertip when said optical probe is attached to a
finger, said cushion being formed in said flexible circuit between
said emitter and said detector, said cushion formed via a hole in
the flexible circuit.
2. The optical probe of claim 1, further comprising an optical
cavity containing said detector.
3. The optical probe of claim 1, further comprising a flexible
backing supporting said flexible circuit.
4. The optical probe of claim 1, wherein said probe comprises a
pulse oximetry sensor.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to low-noise, disposable and reusable
optical probes which may be used to sense optical energy passed
through a medium to determine the characteristics of the
medium.
2. Description of the Related Art
Energy is often transmitted through or reflected from a medium to
determine characteristics of the medium. For example, in the
medical field, instead of extracting material from a patient's body
for testing, light or sound energy may be caused to be incident on
the patient's body and transmitted (or reflected) energy may be
measured to determine information about the material through which
the energy has passed. This type of non-invasive measurement is
more comfortable for the patient and can be performed more
quickly.
Non-invasive physiological monitoring of bodily function is often
required. For example, during surgery, blood pressure and the
body's available supply of oxygen, or the blood oxygen saturation,
are often monitored. Measurements such as these are often performed
with non-invasive techniques where assessments are made by
measuring the ratio of incident to transmitted (or reflected) light
through a portion of the body, for example a digit such as a
finger, or an earlobe, or a forehead.
Transmission of optical energy as it passes through the body is
strongly dependent on the thickness of the material through which
the light passes, or the optical path length. Many portions of a
patient's body are typically soft and compressible. For example, a
finger comprises skin, muscle, tissue, bone, blood, etc. Although
the bone is relatively incompressible, the tissue, muscle, etc. are
easily compressible with pressure applied to the finger, as often
occurs when the finger moves. Thus, if optical energy is made
incident on a finger and the patient moves in a manner which
distorts or compresses the finger, the optical path length changes.
Since a patient generally moves in an erratic fashion, the
compression of the finger is erratic. This causes the change in
optical path length to be erratic, making the absorption erratic,
resulting in a difficult to interpret measured signal.
Many types of non-invasive monitoring devices have been developed
to try to produce a clear and discernable signal as energy is
transmitted through a medium, such as a finger or other part of the
body. In typical optical probes a light emitting diode (LED) is
placed on one side of the medium while a photodetector is placed on
an opposite side of the medium. Many prior art optical probes are
designed for use only when a patient is relatively motionless
since, as discussed above, motion induced noise can grossly corrupt
the measured signal. Typically, probes are designed to maximize
contact between the LED and the medium and the photodetector and
the medium to promote strong optical coupling between the LED, the
medium, and the photodetector, thereby generating a strong output
signal intensity. In this way, a strong, clear signal can be
transmitted through the medium when the patient is generally
motionless.
For example, U.S. Pat. No. 4,880,304 to Jaeb, et al. discloses an
optical probe for a pulse oximeter, or blood oxygen saturation
monitor, comprising a housing with a flat lower face containing a
central protrusion in which a plurality of light emitting diodes
(LEDs) and an optical detector are mounted. When the probe is
placed on the patient's tissue, the protrusion causes the LEDs and
the detector to press against the tissue to provide improved
optical coupling of the sensor to the skin. In another embodiment
(FIGS. 4a and 4b in the Jaeb patent), the LEDs and the detector are
arranged within a central chamber, generally horizontal with
respect to the tissue on which the probe is placed. A set of
mirrors or prisms causes light to be directed from the LEDs onto
the tissue through a polymer sealant within the chamber, the
sealant providing a contact with the tissue for good optical
coupling with the tissue.
U.S. Pat. No. 4,825,879 to Tan, et al. discloses an optical probe
wherein a T-shaped wrap, having a vertical stem and a horizontal
cross bar, is utilized to secure a light source and an optical
sensor in optical contact with a finger. The light source is
located in a window on one side of the vertical stem while the
sensor is located in a window on the other side of the vertical
stem. The finger is aligned with the stem and the stem is bent such
that the light source and the sensor lie on opposite sides of the
finger. Then, the cross bar is wrapped around the finger to secure
the wrap, thereby ensuring that the light source and the sensor
remain in contact with the finger to produce good optical
coupling.
U.S. Pat. No. 4,380,240 to Jobsis, et al. discloses an optical
probe wherein a light source and a light detector are incorporated
into channels within a slightly deformable mounting structure which
is adhered to a strap. Annular adhesive tapes are placed over the
source and the detector. The light source and detector are firmly
engaged with a bodily surface by the adhesive tapes and pressure
induced by closing the strap around a portion of the body. An
alternative embodiment provides a pressurized seal and a pumping
mechanism to cause the body to be sucked into contact with the
light source and detector.
U.S. Pat. No. 4,865,038 to Rich, et al. discloses an optical probe
having an extremely thin cross section such that it is flexible. A
die LED and a die photodetector are located on a flexible printed
circuit board and encapsulated by an epoxy bead. A spacer, having
circular apertures positioned in alignment with the LED and
photodetector, is placed over the exposed circuit board. A
transparent top cover is placed over the spacer and is sealed with
a bottom cover placed under the circuit board, thereby sealing the
probe from contaminants. A spine may be added to strengthen the
device. The flexibility of the device allows it to be pinched onto
the body causing the epoxy beads over the LED and the photodetector
to protrude through the apertures in the spacer and press against
the top cover such that good optical contact is made with the
body.
U.S. Pat. No. 4,907,594 to Muz discloses an optical probe wherein a
dual wall rubberized sheath is fit over a finger. A pump is located
at the tip of the finger such that a pressurized chamber may be
formed between the two walls, thereby causing an LED and a
photodetector located in the inner wall to be in contact with the
finger.
Each of the above described optical probes is designed to cause a
strong measured signal at the photodetector by optimizing contact
between the LED, the patient, and the probe. However, this
optimization forces compressible portions of the patient's body to
be in contact with surfaces which compress these portions of the
patient's body when the patient moves. This can cause extreme
changes in the thickness of material through which optical energy
passes, i.e., changes in the optical path length and changes due to
scattering as a result of venous blood movement during motion.
Changes in the optical path length can produce enough distortion in
the measured signal to make it difficult or impossible to determine
desired information.
Furthermore, demand has increased for disposable and reusable
optical probes which are suitably constructed to provide low-noise
signals to be output to a signal processor in order to determine
the characteristics of the medium. Many difficulties relating to
motion-induced noise have been encountered in providing such an
optical probe inexpensively. Furthermore, such probes tend to be
difficult to use in certain applications, such as applications
where a patient's finger may move or shift during measurement, or,
in a more extreme case, when the optical probe is employed on small
children who typically do not sit still during the measurement
process.
Thus, a need exists for a low-cost, low-noise optical probe which
is easy to use under adverse conditions, and for a method of
manufacturing such a probe. More specifically, a need exists for a
probe which reduces motion induced noise, or motion artifacts,
during measurement of a signal while still generating a transmitted
or reflected signal of sufficient intensity to be measured by a
detector.
SUMMARY OF THE INVENTION
The present invention involves a probe for use in non-invasive
energy absorption (or reflection) measurements. One aspect of the
present embodiment involves an optical probe for non-invasive
measurement of characteristics of a medium, wherein the prove has
an emitter which transmits optical radiation and a detector
configured to detect the optical radiation transmitted by the
emitter. The probe also has a flexible circuit assembly having
circuit paths for connection with the emitter and the detector. A
substrate forms a surface of the flex circuit assembly between the
detector and the emitter. The substrate is constructed to minimize
light piping from the emitter to the detector.
In one embodiment, the probe further has a flexible backing
supporting the flex circuit, the flexible backing being configured
to attach the optical probe to the medium. Advantageously, a an
optical cavity is provided for the detector.
In one advantageous embodiment, the flexible circuit assembly is
sufficiently flexible to provide spring action to minimize optical
decoupling between the emitter and the detector due to
perturbations of the medium. Advantageously, a flexible backing
supporting the flex circuit is configured to affix the optical
probe to the medium. Also, in one preferred embodiment, the flex
circuit has an optical obstruction between the emitter and the
detector.
In one preferred embodiment, the optical obstruction comprising an
aperture through the flex circuit configured to receive a fingertip
when the optical probe is affixed to a finger. The aperture
stabilizes the finger within the probe so as to reduce optical
decoupling between the emitter and the detector.
Preferably, the probe has an optical cavity containing the
detector. In one advantageous embodiment, the optical cavity
containing the detector is coated with a material which absorbs
ambient light or the cavity is made from an ambient light
absorptive material.
A further aspect of the present invention involves an probe for the
non-invasive measurement of characteristics of a medium. According
to this aspect, the optical probe has an emitter which transmits
optical radiation and a detector configured to detect the optical
radiation after attenuation through the medium. Again, a flexible
circuit assembly extending between the emitter and the detector has
electrical circuit paths for the detector and the emitter. A
cushion positioned between the detector and the emitter along the
flexible circuit is also provided. The cushion is preferably formed
in the flexible circuit between the emitter and the detector so
that the cushion abuts a patient's fingertip when the optical probe
is attached to the fingertip.
Another aspect of the present invention involves an optical probe
for the non-invasive measurement of characteristics of a medium,
wherein the probe has a substrate which forms a surface for the
probe such that the substrate is constructed to have a
V-configuration with the emitter and detector positioned on
opposite branches of the V-configuration. This configuration is
advantageous for use with a newborn baby.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 illustrates a schematic medium comprising N different
constituents.
FIG. 2a illustrates an ideal plethysmographic signal that would be
measured by the optical probe of the present invention when
utilized for pulse oximetry.
FIG. 2b illustrates a realistic signal measured by the optical
probe of the present invention when utilized for pulse
oximetry.
FIG. 3 is a perspective view of a probe of the present invention
having a single segment chamber.
FIG. 4 is a cross-sectional view of an optical probe of the present
invention illustrating a single segment chamber having a detector
within it.
FIG. 5 is a cross-sectional view of a probe of the present
invention having a detector resting on a shell of base
material.
FIG. 6 is a cross-sectional view of a probe of the present
invention incorporating a light collecting lens.
FIG. 7 is a cross-sectional view of a probe of the present
invention illustrating a single segment chamber having an LED
within it.
FIG. 8 is a cross-sectional view of a probe of the present
invention incorporating a collimating lens assembly.
FIG. 9 is a cross-section view of a probe of the present invention
wherein the LED and the detector are not aligned along the central
axis of the chamber.
FIG. 10 is a perspective view of another embodiment of a probe of
the present invention having a two segment chamber.
FIG. 11 is a cross-sectional view of another embodiment of the
probe of FIG. 10 incorporating a two segment chamber having a
detector within it.
FIG. 12 is a cross-sectional view of another embodiment of the
probe of FIG. 10 incorporating a light collecting lens in a two
segment chamber.
FIG. 13 is a perspective view of a probe of the present invention
having a three segment chamber.
FIG. 14 is a cross-sectional view of the probe of FIG. 13
incorporating a three segment chamber having a detector within
it.
FIG. 15 is a cross-sectional view of another embodiment of the
probe of FIG. 13 incorporating a light collimating lens.
FIG. 16 is a perspective view of a probe of the present invention
specifically designed to be used with a digit.
FIG. 17 illustrates a schematic finger comprising fingernail, skin,
bone, tissue, muscle, blood, etc.
FIG. 18 is a cross-section view of the probe of FIG. 16.
FIG. 19 is a longitudinal cross-sectional view of the probe of FIG.
16.
FIG. 20 is a cross-sectional view of another embodiment of the
probe of FIG. 16 incorporating a light collecting lens.
FIG. 21 is a cross-sectional view of a probe of the present
invention designed to be utilized for reflectance measurements.
FIG. 22 is a cross-sectional view of a probe which is
advantageously used for non-invasive measurements when a material
is compressible on more than one side. The probe has two bases,
each with a chamber to house a detector or an energy source and
thereby reduce motion artifacts.
FIG. 23 is a cross-sectional view of a probe having a generally
cone-shaped chamber with a reflective surface which advantageously
causes energy to be concentrated, or "funneled," onto the surface
of a detector within the chamber, improving the measured
signal.
FIG. 24 is a schematic of one system which may advantageously
employ a probe of the present invention.
FIG. 25 is a cross-sectional view of a probe wherein the aperture
is filled with a compressible scattering medium.
FIG. 26 is a cross-sectional view of a probe wherein the LED is
spaced from the material to be measured by a transmission assembly
having a scattering medium interposed between the LED and the
material.
FIG. 27 is a cross-sectional view of a probe wherein a scattering
medium is interposed between the LED and the material as well as
between the material and the photodetector.
FIG. 28 is a cross-sectional view of a preferred embodiment of a
probe in accordance with the present invention having an immersion
lens for the photodetector and for the LED and having scattering
medium interposed between the LED and the test material as well as
between the test material and the photodetector.
FIGS. 29A-29B are perspective views illustrating the use of one
embodiment of the disposable optical probe of the present invention
to measure the characteristics of a human fingertip.
FIG. 30 is a flow chart which details a method of manufacturing the
low-noise optical probe shown in FIGS. 29A-29B.
FIG. 31 depicts a first step of the manufacturing process, wherein
multiple rows of flex circuit panels are etched onto a flex circuit
panel comprising, for example, copper/MYLAR (tm), copper/CAPTON
(tm), or conductive ink/MYLAR (tm).
FIG. 31A depicts the placement of detector shields on pressure
sensitive adhesive at detector end of the flex circuit.
FIG. 31B illustrates a second step in the manufacturing process,
wherein components are placed and soldered onto the flex circuits
of FIG. 31.
FIGS. 32A and 32B illustrate a third step in the manufacturing
process, wherein the flex circuits are placed onto a strip of flex
circuit shield material.
FIGS. 33A and 33B depict a fourth step of the manufacturing
process, wherein the flex circuit assemblies are die cut and the
shields are folded over the flex circuits to provide the completed
flex circuit assemblies.
FIG. 34 illustrates a fifth step of the manufacturing process,
wherein a connector tab and a detector cavity are placed onto a
sheet of base material.
FIG. 35 depicts a sixth stage of the manufacturing process, wherein
the flex circuit assembly is positioned on the base material.
FIG. 36 illustrates a seventh step in the manufacturing process,
wherein a cover is placed over the detector cavity.
FIG. 37 illustrates an eighth step of the manufacturing process,
wherein face stock is placed over the flex circuit assembly on the
base material.
FIG. 38 illustrates a ninth step of the manufacturing process,
wherein the optical probe is die cut to the final shape shown in
FIG. 29a.
FIGS. 39A-39C illustrate an optical cavity in detail.
FIGS. 40A and 40B illustrate the application of the a neonatal
probe made in accordance with the present invention.
FIG. 41 is a flow chart which details the general method used for
manufacturing a neonatal disposable optical probe in accordance
with a second embodiment of the present invention.
FIG. 42 illustrates a first step of the manufacturing process for a
neonatal embodiment of the low-noise optical probe, wherein a first
layer of tape is laid out.
FIG. 43 illustrates a second step in the manufacturing process for
the neonatal probe, wherein a second elongated layer of tape is
laid out over the first layer of FIG. 41.
FIGS. 44A-44C illustrate an optical cavity in detail.
FIGS. 45A-45C illustrate the manufacture of the neonate flex
circuit assembly.
FIG. 46 illustrates a third step in the manufacturing process for
the neonatal probe, wherein the flex circuit is laid out with a
connector as well as an optical probe onto the second layer of
tape.
FIG. 47 illustrates a fourth step in the manufacturing process of
the neonatal probe, wherein the third and fourth layers of tape are
laid over the flex circuit.
FIG. 48 illustrates a fifth step in the manufacturing process
wherein the neonatal probe is die-cut to the final shape.
FIGS. 49 and 50 depict an alternative embodiment of the neonatal
probe wherein a soft, hospital wrap is used to affix the probe to a
newborn's foot.
FIGS. 51-54 illustrate an alternative method of manufacturing the
neonate probe.
FIGS. 55A-55C depict a cover which is affixed over the optical
cavity.
FIG. 56 depicts a clip-on version of the optical probe.
DETAILED DESCRIPTION OF THE INVENTION
Examination of a material is often advantageous, especially when it
is difficult or expensive to procure and test a sample of the
material. For example, in physiological measurements, it is often
desirable to monitor a patient without drawing of blood or tissue
from the patient. The known properties of energy absorption as
energy propagates through a material may be used to determine
information about the material through which the energy has passed.
Energy is made incident on a material, and a measurement is made of
energy either transmitted by or reflected from the material.
The amplitude of the measured signal is highly dependent on the
thickness of the material through which the energy passes, or the
optical path length, as well as other properties such as the
erratic movement of venous blood during motion. A schematic medium
20 comprising N different constituents A.sub.1 through A.sub.N is
shown in FIG. 1. Energy transmitted through the medium 20 is
approximately attenuated according to the equation: ##EQU1##
where .epsilon..sub.i is the absorption coefficient of the i.sup.th
constituent; x.sub.i is the thickness of the i.sup.th constituent
through which light energy passes, or the optical path length of
the i.sup.th ; and c.sub.i is the concentration of the i.sup.th
constituent in thickness x.sub.i.
Since energy absorption is strongly dependent on the thicknesses of
the constituents A.sub.1 through A.sub.N which make up the medium
20 through which the energy passes, when the is thickness of the
medium 20 changes, due to motion for example, the thicknesses of
the individual constituents A.sub.1 through A.sub.N change. This
causes the absorption characteristics of the medium 20 to
change.
Often a medium 20 is under random or erratic motion. For example,
if the medium 20 is an easily compressible portion of a patient's
body, such as a digit, and the patient moves, the medium 20
compresses erratically causing the individual thicknesses X.sub.1
through X.sub.N of the constituents A.sub.1 through A.sub.N to vary
erratically. This erratic variation may cause large excursions in
the measured signal and can make it extremely difficult to discern
a desired signal, as would be present without motion induced noise,
or motion artifacts.
For example, FIG. 2a illustrates an ideal desired signal waveform,
labelled Y, measured in one application of the present invention,
namely pulse oximetry. FIG. 2b illustrates a more realistic
measured waveform S, also measured in a pulse oximetry application,
comprising the ideal desired signal waveform Y plus motion induced
noise, n, i.e. S=Y+n. It is easily seen how motion artifacts
obscure the desired signal portion Y.
FIG. 3 is a perspective view of one embodiment of an optical probe
100 of the present invention which greatly diminishes the effects
of motion artifacts on the measured signal. FIG. 4 shows a
cross-sectional view of the optical probe 100 of the present
invention taken along line 4--4 in FIG. 3. For clarity in the
perspective view of FIG. 3, a material 128 on which measurements
are to be taken is not shown placed adjacent the probe 100.
However, the material 128 on which measurements are to be made is
shown in FIG. 4. As illustrated in FIGS. 3 and 4, a base 110,
having a top 112, a bottom 114, a forward end 116, and a rear end
118, is made of a material which is preferably rigid and opaque. It
will be understood, however, that the probe 100 may be made of
materials which may be rigid, resilient, opaque, or transparent,
for example.
An aperture 120 is formed in the top 112 of the base 110.
Typically, the aperture 120 is located at a point between
one-quarter and one-half of the length of the base 100. The
aperture 120 may be of any shape, including but not limited to
circular, square, or triangular. The aperture 120 forms the opening
to a chamber 122 which may also be of any shape. In one embodiment,
a lateral cross-section (not shown) of the chamber 122 is the same
shape as the aperture. A central axis 124 of the chamber 122 is
defined by a line aligned perpendicular to the aperture 120 and
extending generally through a central portion of the aperture
120.
In the embodiment of FIG. 4, a light source 130, typically a light
emitting diode (LED), is affixed adjacent the material 128, aligned
along the central axis 124 of the chamber 122 opposite the chamber
122. Typically, an adhesive such as medical tape is used to affix
the LED 130 to the material 128. A detector 126, such as a
photodetector, is placed within the chamber 122. A central portion
of the photodetector 126 is generally aligned with the central axis
124 of the chamber 122, typically at the bottom 114 of the chamber
122. The photodetector 126 may be fixed within the chamber 122
according to a number of different methods, including but not
limited to adhesive, a press fit, or clear epoxy resin which
transmits light over a range of wavelengths of interest. Typically,
no matter how the photodetector 126 is held within the chamber 122,
the bottom surface 114 of the chamber 122 is made opaque either via
the press fit or via paint or tape, for example.
It is often the case that materials 128 on which absorption
measurements are performed are, at least in part, easily
compressible. Easily compressible portions of the material 128 are
placed directly adjacent (i.e., above) the chamber 122. The area
surrounding the aperture 120 supports the material covering the
chamber 122. The chamber 122 is wide enough that any compressible
portion of the material 128 located above the aperture 120 may
intrude into the chamber 122. Thus, the material 122 may rest above
or penetrate slightly into the chamber 122 and is thereby shielded
from perturbations which compress the material 128, such as
pressure caused when the material 128 is touched.
In the present embodiment, the depth of the chamber 122 may range
from 0.5 mm to 10 mm in depth, with 2-4 mm preferred, and 3-4 mm
more preferred. Similarly, the diameter of the aperture 120 may, in
the present embodiment, range from 3 mm to 20 mm, as required by
the specific application. For instance, the aperture would be
smaller for neonates than for adults. These sizes have been found
to be effective in reducing perturbations and compression of the
material 128, when the material is human skin.
The chamber 122 is deep enough that the photodetector 126 and the
bottom 114 of the chamber 122 do not come into contact with the
easily compressible portion of the material 128, even when the
material 128 is caused to move. Thus, along the central axis 124 of
the chamber 122 nothing comes into physical contact with the easily
compressible portion of the material 128 and causes it to compress.
With little or no compression of the material 128 in this region,
the thickness of the material 128, or the optical path length of
light energy propagating through the material 128, is substantially
stabilized in the field of view of the photodetector. The movement
of venous blood due to compression is also minimized in the field
of view of the photodetector.
The LED 130 emits light at a known wavelength. The light propagates
through the material 128 and an attenuated signal is transmitted
into the chamber 122 to be received by the photodetector 126. As
light from the LED 130 propagates through the material 128, it is
scattered by the material 128 and is thus transmitted into the
chamber 122 over a broad range of angles in a very complex manner.
Thus, some of the light is caused to be incident on the opaque
walls 123 of the chamber 122 and is absorbed. Although the signal
travels through a greater optical distance to reach the
photodetector 126 at the bottom 114 of the chamber 122 than if the
photodetector 126 were immediately adjacent the material 128, thus
eliminating direct coupling between the photodetector 126 and the
material 128, the resulting degradation to signal intensity is
compensated for by the stabilization of the optical path length and
the resultant reduction of noise in the measured signal. The
photodetector 126 produces an electrical signal indicative of the
intensity of light energy incident on the photodetector 126. The
electrical signal is input to a processor which analyzes the signal
to determine characteristics of the media 128 through which the
light energy has passed.
The opaque quality of the base 110 absorbs ambient light which can
interfere with the signal measured at the photodetector 126. This
further improves signal quality. Further, the opaque bottom 114 of
the chamber 122 protects the photodetector 126 from ambient light
which can obscure the desired signal measured at the photodetector
126. Thus, an accurate measurement of the intensity of the
attenuated signal may be made at the photodetector 126.
An alternative embodiment of the chamber 122 is shown in frontal
cross-section in FIG. 5. A shell 131 of base 110 material covers
the bottom 114 of the chamber 122. The photodetector 126 is mounted
on the shell 131, within the chamber 122, generally aligned with
the LED 130. The photodetector 126 is electrically connected to a
processor through a small hole (not shown) in the shell 131. The
shell 131 shields the photodetector 126 from ambient light which
can seriously degrade the signal-to-noise ratio of the signal
measured at the photodetector 126. It will be understood that the
bottom 114 of the chamber 122 may be formed with or without the
shell in any embodiment of the probe of the present invention.
FIG. 6 shows a frontal cross sectional view of another embodiment
of the probe 100 of the present invention wherein a light
collecting lens 132 is placed within the chamber 122, between the
material 128 which rests above or enters into the chamber 122 and
the photodetector 126. The lens 132 has one generally planar
surface 132a aligned parallel to the aperture 120 in the top 112 of
the base 110, located deep enough within the chamber 122 that any
material 128 which intrudes into the chamber 122 does not contact
the planar surface 132a of the lens 132. Another surface 132b of
the lens 132 is generally convex having its apex directed toward
the photodetector 126 in the bottom 114 of the chamber 122. The
lens 132 may be held in the chamber 122 by a number of means,
including but not limited to optical adhesive, a lens retaining
ring, or a press fit. The chamber 122 functions in the same manner
as described above to stabilize the optical path length and reduce
motion artifacts. The light collecting lens 132 gathers much of the
light which was scattered as it was transmitted through the
material 128 and causes it to be incident on the photodetector 126.
This produces a stronger measured signal.
FIG. 7 shows another embodiment of the probe 100 of the present
invention wherein the positions of the photodetector 126 and the
LED 130 are interchanged. The LED 130 is placed within the chamber
122, typically at the bottom 114 of the chamber 122, generally
aligned with the central axis 124 of the chamber 122. The LED 130
may be fixed within the chamber 122 according to a number of
different methods, including but not limited to a press fit,
adhesive, or clear epoxy resin which transmits light over a range
of wavelengths of interest, such as around the wavelength which the
LED emits. Again, a material 128 is placed on the base 110 having a
compressible portion of the material 128 located directly above the
chamber 122. The photodetector 126 is attached to the material 128,
opposite the LED 130, such that the LED 130, the photodetector 126,
and the chamber 122 are aligned along the central axis 124 of the
chamber 122. The photodetector 126 is typically attached by an
opaque material. For example, the photodetector 126 may be attached
to the material 128 with opaque tape, thereby limiting signal
degradation caused by ambient light. The photodetector 126 is,
again, electrically connected to a processor.
The probe 100 of this embodiment functions substantially
identically to the embodiment of the probe 100 having the
photodetector 126 housed in the chamber 122. The chamber 122
stabilizes the optical path length by allowing easily compressible
portions of the material 128 to rest above or intrude into the
chamber 122, thereby stabilizing the optical path length and
substantially reducing motion artifacts. This is true regardless of
whether the photodetector 126 or the LED 130 is housed within the
chamber 122.
FIG. 8 shows a cross-sectional view of another embodiment of the
probe 100 of the present invention wherein the LED 130 is located
within the chamber 122. A collimating lens assembly 140 is placed
within the chamber 122, between the material 128 which rests above
or enters into the chamber 122 and the LED 130. Collimating lens
assemblies 140 are well known in the art and, thus, the lens
assembly 140 is represented schematically in the FIG. 8. The
collimating lens assembly 140 is located deep enough within the
chamber 122 that any material 128 which intrudes into the chamber
122 does not contact the lens assembly 140. The lens assembly 140
may be held in the chamber 122 by a number of means, including but
not limited to optical adhesive, a lens retaining ring, or a press
fit. The chamber 122 functions in the same manner as described
above to stabilize the optical path length and reduce motion
artifacts. The collimating lens assembly 140 causes light from the
LED 130 to be focused on the material 128 above the chamber 122,
thus providing a less scattered signal transmitted onto the
photodetector 126 surface, thereby utilizing the photodetector 126
more effectively.
FIG. 9 shows another embodiment of the probe 100 of the present
invention wherein the LED 130 and the photodetector 126 are not
aligned along the central axis 124 of the chamber 122. Light is
scattered within the material 128, causing at least a portion of
the light emitted by the LED 130 to reach the photodetector 126 for
measurement. As long as light emitted by the LED 130 and scattered
by the material 128 reaches the photodetector 126 with great enough
intensity to be measured, the LED 130 and the photodetector 126
need not be aligned. While alignment of the LED 130 and the
photodetector 126 along the same axis causes the light emitted by
the LED 130 to reach the photodetector 126 more directly, it is not
necessary for operation of the probe of the present invention. In
some applications, misalignment may even be advantageous. It will
be understood that this is true for any embodiment of the probe of
the present invention. Additionally, it will be understood that a
photodetector 126 which fills the width of the chamber 122 is
advantageous in that more of the light directed into the chamber
122 will be incident on the surface of the photodetector 126,
resulting in a stronger measured signal. However, any size
photodetector 126 which acquires enough energy to produce an
adequately strong measured signal is acceptable. It will be
understood that this is true for any embodiment of the probe of the
present invention.
A perspective view of another embodiment of a probe 200 of the
present invention comprising a multi-segment chamber 222 is shown
is FIG. 10. FIG. 11 shows a cross-sectional view of the probe 200
of the present invention taken along line 11--11 in FIG. 10. For
clarity in the perspective view of FIG. 10, a material 228 on which
measurements are to be taken is not shown placed adjacent the probe
200. However, the material 228 is shown adjacent the probe 200 in
FIG. 11.
As illustrated in FIGS. 10 and 11, a base 210, having a top 212, a
bottom 214, a forward end 216, and a rear end 218, is made of a
material which is preferably rigid and opaque. It will be
understood, however, that the probe 200 may be made of materials
which may be rigid, resilient, opaque, or transparent, for example.
An aperture 220 of any shape is formed in the base 210, similar to
the aperture 120 described above in conjunction with the probe 100
of FIGS. 3 through 9. The aperture 220 forms the opening to a
stabilizing segment 222a of the multiple segment chamber 222. A
lateral cross-section (not shown) of the stabilizing segment 222a
of the chamber 222 is typically the same shape as the aperture 220.
Walls 223a of the stabilizing segment 222a are generally
perpendicular to the aperture 220. A central axis 224 of the
chamber 222 is defined by a line aligned generally perpendicular to
the aperture 220 and extending generally through a central portion
of the aperture 220 and the chamber 222.
A mounting segment 222b is located directly adjacent and below the
stabilizing segment 222b, connected to the stabilizing segment 222b
by a border 225. The mounting segment 222b shares the central axis
224 of the stabilizing segment 222a and is typically of smaller
width. Walls 223b of the mounting segment 222b are generally
parallel to the central axis 224. The mounting segment 222b may
extend through the bottom 214 of the base 210, as shown in FIG. 11,
or the mounting segment 222b may extend to just above the bottom
214 of the base 210, leaving a shell (not shown) of base 210
material at the bottom 214 of the chamber 222.
A photodetector 226 is placed in the mounting segment 222b of the
chamber 222, typically at the bottom 214 of the mounting segment
222b, having a central portion of the photodetector 226 generally
aligned with the central axis 224 of the chamber 222. The mounting
segment 222b of the chamber 222 is deep enough that the
photodetector 226 does not penetrate into the stabilizing segment
222 of the chamber 222. The photodetector 226 may be fixed within
the chamber 222 according to a number of different methods,
including but not limited to adhesive, a press fit, or a clear
epoxy resin which transmits light over a range of wavelengths of
interest. In this embodiment, the bottom 214 of the chamber 222 is
made opaque via paint or tape, for example, or by leaving a shell
(not shown) of base 210 material at the bottom 214 of the chamber
222 when the chamber 222 is formed. The photodetector 226 is
electrically connected to a processor, similarly to the
photodetector 126 in the previous embodiment of the probe 100 of
the present invention.
An energy absorbing material 228 (the material under test) is
placed over the base 210 as shown in the cross section of FIG. 11.
A portion of the material 228 may rest above the chamber 222.
Additionally, the stabilizing segment 222a of the chamber 222 is
wide enough that any easily compressible portion of the material
228 may intrude into the stabilizing segment 222a of the chamber
222. The stabilizing segment 222a of the chamber 222 is deep enough
that the portion of the material 228 which enters into the
stabilizing segment 222a does not contact matter within the
stabilizing segment 222a which might cause compression, even when
the material 228 is caused to move.
A light emitting diode (LED) 230 is affixed adjacent to the
material 228, opposite the aperture 220. The LED 230 is
advantageously aligned along the central axis 224 to optimize the
amount of light incident directly through the material 228 onto the
photodetector 226. However, it will be understood that the
positions of the photodetector 226 and the LED 230 could be
interchanged as discussed in conjunction with FIG. 7. Additionally,
a collimating lens assembly (not shown) could be added to the
chamber 222 as discussed in conjunction with FIG. 8. The
collimating lens assembly may be held in the chamber 222 similarly
to a light collecting lens 232 discussed below. Further, it will be
understood that the LED 230 and the photodetector 226 could be
unaligned, as discussed in conjunction with FIG. 9.
As light from the LED 230 propagates through the material 228, it
is scattered by the material 228 and is thus transmitted into the
chamber 222 over a broad range of angles. Thus, some of the light
is caused to be incident on the opaque walls 223a and 223b of the
chamber 222 and is absorbed. However, the advantageous alignment of
the photodetector 226 and the LED 230 along the central axis 224
causes a large percentage of the light to be incident on the
surface of the photodetector 226. Since the material 228 remains
substantially uncompressed above and within the stabilizing segment
222a, the thickness through which the light travels, or the optical
path length, is substantially stabilized. Thus, the signal-to-noise
ratio of the measured signal is improved by the suppression of
motion artifacts due to the chamber 222.
In another embodiment of the probe 200, a light collecting lens 232
is inserted within the chamber 222, as shown in cross-section in
FIG. 12. The lens 232 is advantageously supported at the border 225
between the stabilizing segment 222a and the mounting segment 222b.
The lens may be held in place by a number of means, including but
not limited to an optical adhesive, a lens retaining ring, or a
press fit. The lens 232 has a generally planar surface 232a aligned
with the border 225 between the stabilizing segment 222a and the
mounting segment 222b and a generally convex surface 223b extending
into the mounting segment 222b of the chamber 222. The stabilizing
segment 222a of the chamber 222 is deep enough that the lens 232
does not contact any of the compressible material 228 which may
have intruded into the chamber 222.
The lens 232 collects light which is incident on the planar surface
232a. Much of the light which is incident on this surface 232a at
angles which would be absorbed by the walls 223a and 223b of the
chamber 222 if the lens were not present is now directed toward the
photodetector 226. Thus, a greater percentage of the light
transmitted through the material 228 is caused to be incident on
the photodetector 226, resulting in a stronger measured signal.
A perspective view of another embodiment of the probe 300 of the
present invention which incorporates a chamber 322 having three
segments 322a, 322b, and 322c is shown in FIG. 13. The probe 300
has a base 310 with a top 312, a bottom 314, a forward end 316, and
a rear end 318. The base 310 is typically made of rigid opaque
material. However, it will be understood that the base 310 may be
made of other materials which may be rigid, resilient, opaque, or
transparent, for example. A cross-sectional view of the chamber 322
of this embodiment is shown in FIG. 14. For clarity in the
perspective view of FIG. 13, a material 328 on which measurements
are to be taken is not shown placed adjacent the probe 300.
However, the material 328 is shown in the cross section of FIG. 13.
An aperture 320 of any shape is formed in the base 310, similar to
the apertures 120 and 220 described above. The aperture 320 forms
the opening to a stabilizing segment 322a of a three segment
chamber 322. A lateral cross-section (not shown) of the stabilizing
segment 322a of the chamber 322 is typically the same shape as the
aperture 320. Walls 323a of the stabilizing segment 322a are
generally perpendicular to the aperture 320. A central axis 324 of
the chamber 322 is defined by a line aligned perpendicular to the
aperture 320 and extending generally through a central portion of
the aperture 320 and the chamber 322.
A second, transitional segment 322b of the chamber 322 is adjacent
the stabilizing segment 322a of the chamber 322. A top border 325a
is formed between the transitional segment 322b and the stabilizing
segment 322a of the chamber 322. The transitional segment 322b
shares the same central axis 324 as the stabilizing segment 322a.
Walls 323b of the transitional segment 322b are angled inwardly
such that a bottom border 325b of the transitional segment 322b is
of smaller dimension than the top border 325a of the transitional
segment 322b.
The bottom border 325b of the transitional segment 322b leads into
a mounting segment 322c of the chamber 322. The mounting segment
322c shares the same central axis 324 of the stabilizing and
transitional segments 322a and 322b and is typically of smaller
width than the stabilizing and transitional segments 322a and 322b.
Walls 323c of the mounting segment 322c are generally parallel to
the central axis 324. Thus, any cross-section of the mounting
segment 322c cut perpendicular to the central axis 324 of the
chamber 322 is typically of approximately the same shape as the
bottom border 325b of the transitional segment 322b of the chamber
322. The mounting segment 322c may extend through the bottom 314 of
the base 310, as shown. Alternatively, the mounting segment 322c
may extend to just above the bottom 314 of the base 310, leaving a
shell (not shown) of base 310 material at the bottom 314 of the
three segment chamber 322.
A photodetector 326 is placed within the mounting segment 322c of
the chamber 322, at the bottom 314 of the chamber 322 in the
present embodiment. A central portion of the photodetector 326 is
aligned with the central axis 324 of the chamber 322. The mounting
segment 322c of the chamber 322 is deep enough that the
photodetector 326 does not penetrate into the stabilizing segment
322 of the chamber 322. The photodetector 326 may be fixed within
the chamber 322 according to a number of different methods,
including but not limited to adhesive, a press fit, or a clear
epoxy resin which transmits light over a range of wavelengths of
interest. In this embodiment, the bottom 314 of the chamber 322 is
made opaque via the press fit, paint, or tape, for example. The
photodetector 326 is electrically connected to a processor,
similarly to the photodetectors 126 and 226 in the previous
embodiments of the probe of the present invention.
When a portion of an energy absorbing material 328 is placed over
the probe 300, as shown in the cross-section of FIG. 14, it may
rest above the chamber 322. Additionally, the stabilizing segment
322a of the chamber 322 is wide enough that easily compressible
portions of the material 328 may enter into the stabilizing segment
322a of the chamber 322. The stabilizing segment 322a of the
chamber 322 is deep enough that the easily compressible portion of
the material 328 which intrudes into the stabilizing segment 322a
does not contact matter within the stabilizing segment 322a which
might cause compression of the material 328, even when the material
328 is caused to move. The chamber 322 shields the compressible
material 328 from contact which might cause compression of the
material 328 and thereby change the optical path length through the
material 328.
An LED 330 is affixed to the material 328, opposite the aperture
320. The LED 330 is advantageously aligned along the central axis
324 to optimize the amount of light incident directly through the
material 328 onto the photodetector 326. It will be understood that
the positions of the photodetector 326 and the LED 330 could be
interchanged as discussed in conjunction with FIG. 7. Additionally,
a collimating lens assembly (not shown) could be added to the
chamber 322 as discussed in conjunction with FIG. 8. The
collimating lens assembly may be held in the chamber 322 similarly
to a light collecting lens 332 discussed below. Further, it will be
understood that the LED 330 and the photodetector 326 could be
unaligned, as discussed in conjunction with FIG. 9.
As light from the LED 330 propagates through the material 328, it
is scattered by the material 328 and is thus transmitted into the
chamber 322 over a broad range of angles. Thus, some of the light
is caused to be incident on the opaque walls 323a, 323b, and 323c
of the chamber 322 and is absorbed. However, the advantageous
alignment of the photodetector 326 and the LED 330 along the
central axis 324 of the chamber 322 causes a large percentage of
the light to be incident on the surface of the photodetector 326.
Since the material 328 remains substantially undompressed above and
within the stabilizing segment 322a, the thickness through which
the light travels, or the optical path length, is substantially
stabilized. Thus, the signal-to-noise ratio of the measured signal
is improved by the suppression of motion artifacts. Additionally
helping to improve the signal to noise ratio of the measured signal
is the opaque bottom 314 of the mounting segment 322c which
shelters the photodetector 326 from ambient light.
In another embodiment of the probe 300 of the present invention, a
light collecting lens 332 is added to the transitional segment 322b
of the chamber 322, as shown in a cross sectional view in FIG. 15.
The lens 332 is supported in the transitional segment 322b and may
be held in the transitional segment 322b by a number of means,
including but not limited to optical adhesive, a lens retaining
ring, or a press fit. The lens has a generally planar surface 332a
aligned with the top border 325a of the transitional segment 322b
of the chamber 322 and a generally convex surface 325b extending
into the transitional segment 322b of the chamber 322. The
stabilizing segment 322a of the chamber 322 is deep enough that the
lens 332 does not contact the easily compressible material 328
which rests above or has intruded into the chamber 322.
The lens 332 collects light which is incident on the planar surface
332a Much of the light which is incident on this surface 332a at
angles which would have been absorbed by the walls 323a, 323b and
323c of the chamber 322 if the lens 332 were not present is now
directed toward the photodetector 326. Thus, a greater percentage
of the light transmitted through the material 328 is caused to be
incident on the photodetector 326, resulting in a stronger measured
signal.
It will be understood that the walls 323b of the transitional
segment 322b in each of the above described embodiments need not be
sloped to achieve transition from larger width in the stabilizing
segment 322a to smaller width in the mounting segment 322c. The
walls 323b of the transitional segment 322b could be aligned
generally parallel to the central axis 324, arranged at a distance
which would cause the width of the transitional segment 322b to be
less than the width of the stabilizing segment 322a and greater
than the width of the mounting segment 322c.
FIG. 16 shows a perspective view of another probe 400 of the
present invention specifically designed for use with a digit, such
as a finger or a toe. For ease of illustration, the present example
will pertain to a finger, though it will be understood that the
present example could equally well pertain to any digit. FIG. 17
illustrates a schematic finger 428 comprising nail, skin, bone,
tissue, muscle, blood, etc. Constituents in the finger's pad 404,
such as fat and tissue, are easily compressible with motion of a
patient. Even slight motion of the finger 428 can cause the
thickness of constituents within the finger 428 to change greatly,
thereby causing large motion induced excursions to occur in a
measured signal, often obscuring a desired portion of the measured
signal from which information about the patient can be
determined.
As depicted in FIG. 16, base 410 of the finger probe 400, called a
saddle 410 in this embodiment, is generally semi-cylindrical and
preferably is made of a rigid or semi-rigid, opaque material such
as black plastic. It will be understood, however, that the saddle
410 may be made of other materials, including those which are
rigid, resilient, opaque, and transparent, for example. The saddle
410 has a top 412, a bottom 414, a forward end 416, a rear end 418,
a ridge 440, and sidewalls 450 which curve upwardly from the ridge
440 to form a U-shape in cross-section, as shown in FIG. 18.
As illustrated in FIGS. 16 and 18, an aperture 420 forms the
entrance to a chamber 422, located between one-quarter to one-half
of the length of the saddle 410 from the forward end 416 of the
saddle 410, as shown in the longitudinal cross-section of FIG. 19.
The aperture 420 can be of any shape, including but not limited to
circular, square, or triangular. The aperture 420 is the entrance
to a chamber 422, as described previously in conjunction with other
embodiments 100, 200, and 300 of the probe of the present
invention. The chamber 422 may also be of any shape, including but
not limited to circular, square, or triangular in
cross-section.
The chamber 422 may have one or more segments, as described
previously. Although the chamber 422 shown in this embodiment is a
three segment chamber 422, having a stabilizing segment 422a, a
sloped-wall transitional segment 422b, and a mounting segment 422c
aligned on a common central axis 424, it will be understood that
any chamber 422 which protects from compression, a compressible
portion of the finger 428 through which light energy passes during
absorption measurements, is a viable alternative. It will further
be understood that a shell (not shown) of saddle 410 material could
cover the bottom 414 of the chamber 422, as described previously
with respect to the embodiment of the probe shown in FIG. 5.
A photodetector 426 is placed within the chamber 422, typically at
the bottom 414 of the mounting segment 422c of the chamber 422. The
photodetector 426 may be in place by adhesive, a press fit, or a
clear epoxy resin which transmits light over a range of wavelengths
of interest, for example. Typically, the bottom 414 of the chamber
422 is made opaque via tape or paint, for example, such that
ambient light does not affect the photodetector 426.
The finger 428 is placed on the saddle 410, the finger pad 404
directly adjacent the aperture 420 and chamber 422. Additionally,
the finger pad 404 may rest above the chamber 422. The aperture 420
and stabilizing segment 422a of the chamber 422 are wide enough
that any easily compressible portion of the finger 428, such as a
portion of the finger pad 404, may intrude into the chamber 422.
The stabilizing segment 422a of the chamber 422 is deep enough that
any portion of the finger 428 which does penetrate into the
stabilizing segment 422a does not contact any matter within the
stabilizing segment 422a which might cause compression of the
finger 428, even when the finger 428 is caused to move.
An LED 430 is affixed to the finger 428, generally opposite the
aperture 420. The LED 430 is typically attached to the finger 428
via adhesive, such as medical tape. The LED 430 is advantageously
aligned along the central axis 424 to optimize the amount of light
transmitted directly through the finger 428 onto the photodetector
426. However, it will be understood that the positions of the
photodetector 426 and the LED 430 could be interchanged as
discussed in conjunction with FIG. 7. Additionally, a collimating
lens assembly (not shown) could be added to the chamber 422 as
discussed in conjunction with FIG. 8. The collimating lens assembly
may be held in the chamber 422 similarly to a light collecting lens
432 discussed below. Further, it will be understood that the LED
430 and the photodetector 426 could be unaligned, as discussed in
conjunction with FIG. 9.
The LED 430 emits a light energy signal which propagates through
the finger 428 and is transmitted into the chamber 422. The chamber
422 shields from compression the portion of the finger 428 through
which light energy passes. Thus, the optical path length of the
light through the finger 428 is substantially stabilized and motion
artifacts are substantially reduced in the measured signal. It will
be understood that a single segment chamber as described in
conjunction with FIGS. 3 through 9 or a two segment chamber as
described in conjunction with FIGS. 10 through 12 could equally
well be used in the finger probe 400 of the present invention to
shield the compressible portion of the finger 428 from compression
and thereby reduce motion artifacts.
FIGS. 16, 18, and 19 illustrate a perspective view, a frontal
cross-sectional view, and a longitudinal cross-sectional view,
respectively, of one embodiment of the finger probe 400. The
curvature of the saddle 410 is correlated to the average curvature
of the finger 428 such that the sidewalls 450 form a semi-circular
splint-type support for the finger 428. The saddle 410 is
approximately 25 mm long between the forward end 416 and the rear
end 418, such that a portion of the finger 428 between its tip 406
and approximately its first knuckle 408 (shown in FIG. 17) fits
between the front 416 and the rear 418 ends of the probe 400. The
curvature of the saddle 410 is generally defined by a line 460
(shown in FIG. 18) which is tangent to a sidewall 450 at an angle
between 30.degree. and 50.degree. from horizontal.
The placement of the aperture 420 at a point between one-third and
one-half of the length of the saddle 410, causes the thickest
section of the compressible portion of the finger 428, or the
finger pad 404, to rest above and within the chamber 422. Thus, the
portion of the finger 428 with the greatest amount of compressible
material is safeguarded from compression by the chamber 422.
In the embodiment of the finger probe 400 shown in FIGS. 16, 18,
19, and 20, the aperture 420 is generally circular and the chamber
422 has three segments 422a, 422b, and 422c, as shown in the
cross-sectional view of FIG. 18. Advantageously employed dimensions
for the finger probe 400 illustrated in FIGS. 16, 18, 19, and 20
include the stabilizing segment 422a of the chamber 422 being
generally cylindrical and having a diameter of approximately seven
millimeters. Additionally, the stabilizing segment 422a of the
chamber 422 is deep enough that any portion of the finger 428 which
penetrates into the chamber remains substantially free of
perturbation, even when the finger 428 moves. An advantageous depth
for the stabilizing segment 422a is thus approximately two
millimeters deep. The mounting segment 422c of the chamber 422 is
also cylindrical, having a. diameter of approximately five
millimeters. The transitional segment 422b of the chamber 422 is of
varying diameter, having sloped walls 423b, such that a top border
425a is approximately seven millimeters in diameter and a bottom
border 425b is approximately five millimeters in diameter. A
detector 426 having up to a 5 millimeter diameter is positioned in
the bottom 416 of the mounting segment 422c of the chamber 422.
In another embodiment of the finger probe 400, a light collecting
lens 432 may be added to the finger probe 400 of the present
invention, as shown in FIG. 20. The saddle 410 and the chamber 422
function as discussed above. The lens 432 functions as described
above in conjunction with FIGS. 6, 12, and 15 to collect light
incident on the lens 432 which would be absorbed by the walls 423a,
423b and 423c of the chamber 422 if the lens 432 were not present.
Thus, a greater percentage of the light transmitted through the
finger 428 is directed onto the photodetector 426, resulting in a
stronger measured signal.
Other embodiments of the probe of the present invention may be
specifically designed and manufactured for use with an earlobe or
other thin section of the body, such as a nostril or a lip, using
the principles described herein. Also, embodiments of the probe of
the present invention utilizing the properties of attenuation as
energy is reflected from a medium, rather than transmitted through
a medium, may be made using similar principles.
A probe 700 specifically designed to measure reflected energy is
shown in cross-section in FIG. 21. A base 710 is placed adjacent a
material 728 on which reflectance measurements are to be made. A
photodetector 726 and an LED 730 are located within the base 710.
In the embodiment shown in FIG. 21, the photodetector 726 is
positioned within a chamber 722x and the LED 730 is positioned
within a chamber 722y. Although single segment chambers 722x and
722y are illustrated, the chambers 722x and 722y may be of any
suitable shape and size. The chambers 722x and 722y function to
stabilize the optical path length, as discussed previously, by
shielding from compression any compressible portion of a material
which rests above or intrudes into the chambers 722x and 722y.
A light collecting lens (not shown) may be added to the chamber
722x having the photodetector 726 within it, as discussed
previously in conjunction with FIGS. 6, 12 and 15. Additionally, a
collimating lens assembly (not shown) may be added to the chamber
722y having the LED 730 in it, as discussed previously in
conjunction with FIG. 8. The chambers 722x and 722y may be formed
with or without a shell (not shown) of base 710 material, as
discussed previously in conjunction with FIG. 5.
It will be understood that in other embodiments (not shown) of the
reflectance probe 700, the photodetector 726 could protrude from
the base 710 and the LED 730 be located within a chamber 722y or
the LED 730 could be protrude from the base 710 and the
photodetector 726 could be located within a chamber 722x.
Additionally, the photodetector 726 and the LED 730 could be
located within a single chamber 722. In any embodiment the
chamber(s) 722 may have any number of segments of any suitable
shape.
The type of probe 700 which relies on reflection may be
advantageously utilized on materials where a photodetector 726 and
an LED 730 cannot be placed on opposite sides of the material 728,
such as with the forehead. However, a reflectance probe 700 can be
used anywhere a non-invasive measurement needs to be taken, such as
a lip, an earlobe, or a finger, for example.
FIG. 22 shows a cross-sectional view of another probe 800 of the
present invention wherein two bases 810x and 810y are placed
adjacent to a material 828 on which measurements are to be made.
The bases 810x and 810y are located on opposite sides of the
material 828. A photodetector 826 is placed in a chamber 822x in
the base 810x. An LED 830 is placed in a chamber 822y in the base
810y. The photodetector 826 and the LED 830 are aligned
substantially along a central axis 824. Although two segment
chambers 822x and 822y are illustrated, the chambers 822x and 822y
may be of any suitable shape and size. Independent of which shape
of chamber is utilized, the chambers 822x and 822y function to
stabilize the optical path length and thereby reduce the effects of
motion artifacts on the measured signals.
As discussed previously, the probe 800 may be modified slightly
with a light collecting lens (not shown) added to the chamber 822x
with the photodetector 826 in it. A collimating lens assembly (not
shown) may be added to the chamber 822y with the LED 830 in it.
Additionally, the chambers 822x and 822y may be formed with or
without a shell (not shown) of base 810x and 810y material. The
probe 800 is particularly advantageous when a material 828 is
compressible on more than one side since each chamber 822x and 822y
supports and shields from compression any compressible portion of a
material 828 which rests above or intrudes into the chambers 822x
and 822y, respectively.
FIG. 23 shows a cross-sectional view of another probe 900 of the
present invention wherein a chamber 922 having walls 923 is formed
to concentrate, or "funnel," energy onto the surface of a
photodetector 926. An aperture 920 is formed in a base 910, the
aperture 920 leading to a generally cone-shaped chamber 922. The
base 910 is placed adjacent a material 928 on which measurements
are to be made, the chamber 922 being placed directly adjacent any
easily compressible portion of the material 928. The photodetector
926 is placed within the chamber 922, typically at the bottom of
the chamber 928. A light emitting diode 930 is placed on the
material 928, generally opposite and aligned with the photodetector
926.
As discussed previously, a portion of the material 928 is supported
by the area surrounding the aperture 920. Additionally, the
aperture 920 and chamber 922 are wide enough that any easily
compressible portion of the material 928 may intrude into the
chamber 922 without being compressed, thereby shielding this
portion of the material 928 from compression, even during motion of
the material 928. This substantially stabilizes the optical path
length and improves the signal to noise ratio of the signal
measured at the photodetector 926.
Further improving the signal to noise ratio of measurements made
with the probe 900, reflective material, such as a highly
reflective metal, covers the walls 923 of the chamber 922. This
causes light scattered by the material 928 and made incident on the
walls of the chamber 922 to be reflected. The cone shape causes the
light to be concentrated generally on the photodetector 926.
Depending upon the shape of the photodetector 926, the chamber 922
may be advantageously contoured to maximize the funneling of light
onto the photodetector 926. If the photodetector 926 is flat, the
chamber is most advantageously shaped having a generally hyperbolic
cross-section. However, if the photodetector 926 is spherical or
slightly curved, as is often the case due to manufacturing
processes, the chamber is most advantageously shaped having a
cone-shaped cross-section with uncurved walls 923.
As discussed previously in conjunction with other embodiments of
the probe of the present invention, the probe 900 may be modified
to include a light collecting lens (not shown). Alternatively, an
LED 930 could be placed within the chamber 922 instead of the
photodetector 926. With the LED in the chamber 922, a collimating
lens assembly (not shown) could be placed within the chamber 922.
Two bases 910 with two generally cone-shaped chambers could be
utilized on one or either side of a material 928. A single base 910
with two generally cone-shaped chambers 922 located side by side
could also be used for reflective measurements. Additionally, the
photodetector 926 and the LED 930 need not be aligned along the
central axis 924.
FIG. 24 depicts one embodiment of a probe constructed in accordance
with the present invention coupled to an oximeter. The oximeter
could be any oximeter known in the art which utilizes light
attenuation measurements. A block diagram of one possible oximeter
is depicted in FIG. 24. The oximeter shown in FIG. 24 is a pulse
oximeter wherein the finger probe 400 is employed and two measured
signals at different wavelengths, one of which is typically red and
the other of which is typically infrared, are alternately passed
through the finger 428. Signals measured at the photodetector 426
are then processed to determine the amount of oxygen available to
the body. This is evaluated by finding the saturation of oxygenated
hemoglobin in blood comprising both oxygenated and deoxygenated
hemoglobin.
Two LEDs 430a and 430b, one LED 430a emitting red wavelengths and
another LED 430b emitting infrared wavelengths, are placed adjacent
the finger 428. The finger probe 400 is placed underneath the
finger 428, the aperture 420 and chamber 422 located directly
adjacent the finger pad 404. The photodetector 426 in the bottom
414 of the chamber 422 is connected to a single channel of common
processing circuitry including an amplifier 530 which is in turn
connected to a band pass filter 540. The band pass filter 540
passes signal into a synchronized demodulator 550 which has a
plurality of output channels. One output channel is for signals
corresponding to visible wavelengths and another output channel is
for signals corresponding to infrared wavelengths.
The output channels of the synchronized demodulator 550 for signals
corresponding to both the visible and infrared wavelengths are each
connected to separate paths, each path comprising further
processing circuitry. Each path includes a DC offset removal
element 560 and 562, such as a differential amplifier, a
programmable gain amplifier 570 and 572 and a low pass filter 580
and 582. The output of each low pass filter 580 and 582 is
amplified in a second programmable gain amplifier 590 and 592 and
then input to a multiplexer 600.
The multiplexer 600 is connected to an analog-to-digital converter
610 which is in turn connected to a microprocessor 620. Control
lines between the microprocessor 620 and the multiplexer 600, the
microprocessor 620 and the analog-to-digital converter 610, and the
microprocessor 620 and each programmable gain amplifier 570, 572,
590, and 592 are formed. The microprocessor 620 has additional
control lines, one of which leads to a display 630 and the other of
which leads to an LED driver 640 situated in a feedback loop with
the two LEDs 430a and 430b.
Each of the LEDs 430a and 430b alternately emits energy which is
absorbed by the finger 428 and received by the photodetector 426.
The photodetector 426 produces an electrical signal which
corresponds to the intensity of the light energy striking the
photodetector 426 surface. The amplifier 530 amplifies this
electrical signal for ease of processing. The band pass filter 540
then removes unwanted high and low frequencies. The synchronized
demodulator 550 separates the electrical signal into electrical
signals corresponding to the red and infrared light energy
components. A predetermined reference voltage, V.sub.ref, is
subtracted by the DC offset removal element 560 and 562 from each
of the separate signals to remove substantially constant absorption
which corresponds to absorption when there are no motion artifacts.
Then the first programmable gain amplifiers 570 and 572 amplify
each signal for ease of manipulation. The low pass filters 580 and
582 integrate each signal to remove unwanted high frequency
components and the second programmable gain amplifiers 590 and 592
amplify each signal for further ease of processing.
The multiplexer 600 acts as an analog switch between the electrical
signals corresponding to the red and the infrared light energy,
allowing first a signal corresponding to the red light to enter the
analog-to-digital convertor 610 and then a signal corresponding to
the infrared light to enter the analog-to-digital convertor 610.
This eliminates the need for multiple analog-to-digital convertors
610. The analog-to-digital convertor 610 inputs the data into the
microprocessor 620 for calculation of the saturation of oxygen
according to known methods, such as those described in U.S. patent
application Ser. No. 07/666,060 filed Mar. 7, 1991, and abandoned
in favor of continuation U.S. patent application Ser. No.
08/249,690, entitled "SIGNAL PROCESSING APPARATUS AND METHOD,"
filed May 26, 1994, both assigned to MASIMO CORPORATION, the same
assignee as the present patent, and incorporated herein by
reference. U.S. patent application Ser. No. 08/320,154, entitled
Signal Processing Apparatus, filed on Oct. 7, 1994 is also
incorporated by reference herein. The microprocessor 620 centrally
controls the multiplexer 600, the analog-to-digital convertor 610,
and the first and second programmable gain amplifiers 570, 590,
572, and 592 for both the red and the infrared channels.
Additionally, the microprocessor 620 controls the intensity of the
LEDs 430a and 430b through the LED driver 640 in a servo loop to
keep the average intensity received at the photodetector 426 within
an appropriate range.
As explained above, the probe of the present invention could be
used with a variety of oximeter systems. A recent embodiment of an
oximeter by the assignee of the present application is described in
detail in U.S. patent application Ser. No. 08/320,154, entitled
"Signal Processing Apparatus," and filed Oct. 7, 1994, which patent
application is also incorporated herein by reference.
FIGS. 25-28 depict alternative embodiments of the present invention
wherein an improved signal to noise ratio is observed in the
received signal due to optical scattering effects. A probe 1000,
shown in cross-section in FIG. 25, includes a base 1010, having a
top 1012, a bottom 1014, and a forward and a rear end (not shown in
FIG. 25). The base 1010 is preferably rigid and opaque to the
wavelengths used in the probe 1000. An aperture 1020 is formed in
the top 1012 of the base 1010. The aperture 1020 may be cylindrical
(as shown in FIG. 25), conical, rectangular, or other shapes as
called for by the specific application. The depth of the aperture
1020 may, for example, range from 0.5 mm to 10 mm, and is
preferably in the range of 2-4 mm in depth in one embodiment, and
more preferably in the range of 3-4 mm. Furthermore, the diameter
of the aperture 1020 may range from 3 mm to 20 mm, as called for by
the specific application. It has been found by the inventors that
an aperture less than 0.5 mm in diameter does not obtain the
benefits of the present invention.
A light source 1030 (e.g., one or more light emitting diodes) is
affixed adjacent to material 1028 (e.g., an earlobe, finger, or
other fleshy material), aligned along a central axis 1024 which
passes substantially through the center of a photodetector 1026.
The aperture 1020 is filled wholly, or in part, by a scattering
medium 1040, which may, for example, comprise 2.2 pound
polyurethane reticulated foam (although conformable plastic or
scattering gels may also be employed). In general, the scattering
medium may comprise one of a number of fixotropic materials (i.e.,
materials having two or more mixed materials which are conducive to
scattering). Ideally, the scattering medium 1040 scatters but does
not significantly absorb optical radiation at the operational red
(e.g., 660 nm) and infrared (e.g., 940 nm) wavelengths for the
oximeter. In other words, the material is clear to optical
absorption, but still scatters light.
In operation, the light source 1030 (e.g., two LEDs in the present
embodiment) emits optical radiation (e.g., in the red or infra-red
spectrum range) which passes through the material under test 1028.
The optical radiation is received by the photodetector 1026 after
passing through the scattering medium 1040. The received optical
radiation is scattered by the scattering medium 1040.
The scattering of the optical radiation within the scattering
medium 1040 has been found to increase the signal-to-noise ratio of
the received signal. It is believed that the signal-to-noise ratio
is improved because there appears to be a reduced effect on the
signal from any particular local region of the material 1028 (e.g.,
flesh). That is, by scattering the signal either prior to or
posterior to the material interface, the signal is effectively
spread over a larger area of the material 1028. Thus, perturbations
of a locality within the area of exposure will have less effect
with a scattered beam over a large area than with a more
concentrated signal passing through that same locality. In this
way, the effect of perturbations on the average signal is reduced.
Also, the foam and * plastic cover reduce optical decoupling and
geometric variation in the optical light path during motion.
The scattering medium 1040 or plastic cover should be soft (i.e.,
highly compressible) so that the material 1028 does not
significantly compress when the material 1028 presses against the
scattering medium 1040. Compression of the scattering medium 1040
does not significantly alter the amplitude of the measured signal
since the scattering medium is not highly absorptive of the optical
radiation. Although conformable plastic covers may be used,
reticulated foams provide improved optical coupling with flesh.
This is because the reticulated foam provides contact in spots
rather than across large areas of the flesh. If contact is made
across large areas of flesh, microscopic droplets of perspiration
or oil can form a layer between the flesh and the scattering medium
1040. This layer creates an impedance mismatch interface which is
absorptive of the optical radiation. Of course, gels may also be
used in accordance with the present invention. Such gels should not
contain significant amounts of metal salts or silica because these
materials absorb light.
The teachings of the present invention depart from conventional
methods of improving optical signal-to-noise ratios. Commonly, lens
assemblies which focus optical radiation are used to improve the
signal-to-noise ratios of optical signals. However, oximetry by
means of transmission or reflection is a non-imaging method of
optical detection. Thus, the form of the image is not important for
detection purposes. For this reason, scattering may be used as a
method of improving optical signal quality; whereas, since
scattering was thought to degrade signal-to-noise ratios of optical
signals, previous methods have not employed optical scattering
techniques.
FIGS. 26 and 27 depict further alternative embodiments of the
present invention wherein optical scattering is provided prior to
the flesh interface, and both prior and posterior to the flesh
interface, respectively. In FIG. 26, an oximetry probe 1045 further
has a transmission assembly 1050 which secures the LED 1030 in
place within a backing 1055. A scattering medium 1060, having a
face 1063, is interposed between the LED 1030 and the material
1028. In the embodiment depicted in FIG. 26, the scattering medium
1060 does not contact the LED 1030; however, it should be
understood that the scattering medium 1060 may contact one or both
of the LED 1030 and the material 1028.
The scattering medium 1060 diffuses the optical radiation emitted
by the LED 1030 over a wider area. Thus, the LED 1030, which is
essentially a point source, is transformed into an evenly
distributed source of light over the entire area of the face 1063
of the scattering medium 1060. The diffusion of the light over a
wider area provides an improved signal-to-noise ratio.
As seen in FIGS. 26-28, the light is scattered. This is represented
by the energy intensity contours rather than light path indicators.
As recognized by the present inventors, the particular light path
is not significant. The important aspect is the intensity of the
light and the field of view of the photodetector and the light
source. This will be explained further in connection with the
embodiment of FIG. 28 utilizing an immersion lens.
The operation of a probe 1065 shown in FIG. 27 is essentially the
same as that of the probe 1045, with the exception that the
scattering medium 1040 is provided within the aperture 1020. It has
been found that by providing a scattering medium on both sides of
the material 1028, an improved signal-to-noise ratio is observed
over the probes having a scattering medium on only one side of the
material 1028.
FIG. 28 depicts a preferred embodiment of a probe 1070 in
accordance with the present invention. As depicted in FIG. 28, the
probe 1070 comprises a transmission assembly 1072, having a light
source 1074, an immersion lens 1076, scattering medium 1078, a
chamber 1080 defining an aperture 1082 along a support surface 1083
of the transmission assembly. A detector assembly 1084 is similarly
configured with a support surface 1085, a chamber 1086 defining an
aperture 1088 along the support surface 1085, a photodetector 1090,
an immersion lens 1092 and scattering medium 1094. FIG. 28 further
depicts a test material 2000 such a human tissue (e.g., a finger or
earlobe) interposed between the light source assembly 1072 and the
detector assembly 1084.
Several advantages are obtained from the particular configuration
shown in FIG. 28. First, it should be understood that an economical
way to fabricate the light source in the photodetector is to
utilize small semiconductor LEDs and photodetectors. Such devices
are very small, and therefore, have a very small field of view. The
inventors have recognized that it is advantageous to improve the
field of view of the photodetector and the LED because the surface
of the tissue material 2000 at the aperture of the support surfaces
is large compared to the surface of the semiconductor photodetector
and LED. Thus, without enlarging the field of view of the
photodetector and/or LED, much of the tissue material interface at
the apertures is not utilized. As explained above, scattering of
the light improves the received signal quality. An immersion lens
for the photodetector and/or LED increases the field of view of the
semiconductor photodetector and LEDs such that a substantial
portion of the tissue material covering the apertures is within the
field of view of the photodetector and/or LED.
Because imaging optics are not required due to the advantages of
scattering, a significantly advantageous configuration is to
utilize epoxy placed directly over the photodetector and/or over
the LED in the form of a partial sphere which performs suitably as
an immersion lens in the present embodiment. In one embodiment, the
index of refraction of the epoxy is advantageously 1.56 in the
present embodiment. The epoxy also acts to protect the
photodetector and/or LED. The immersion lens can be formed by
placing a bump of epoxy over the photodetector and the LED.
The immersion lens formed by a bump of epoxy over the photodetector
and/or LED expands the field of view for the photodetector and LED
in order to disperse the transmitted light energy over the tissue
surface area at the apertures which is large relative to the
surface of the optical elements. This assists in minimizing the
effects of the relatively small optical details of the test
materials (e.g., pores, fingerprint lines, sweat glans).
In the advantageous embodiment of FIG. 28, the scattering material
1080, 1086 is also placed in the chambers 1080, 1086 in order to
enhance scattering of the light as explained above.
The cone shaped chambers 1080, 1086 depicted in FIG. 28 are also
advantageous when the walls of the chambers are coated with a
highly reflective material which does not absorb the light from the
LED. The cone shape assists in reflecting the light energy away
from the LED and toward the photodetector. All of these elements in
combination form a particularly advantageous probe which can
maximize the signal-to-noise ratio of the probe and minimize the
effects of motion artifact on the received signal.
It should be understood that in alternative embodiments of the
probe 1070 depicted in FIG. 28, elements could be removed and still
obtain significant benefit. For instance, the detector assembly
1084 could remain the same with the light source assembly 1072
simply becoming an LED with no support surface and no chamber.
Alternatively, the scattering media 1078, 1086 could be removed
from either the chamber 1080 in the light source assembly 1072 or
the chamber 1086 in the detector assembly 1082.
The light collecting lens, or other optical elements, could also be
added to the chamber in any optical probe of the present invention
to direct light onto the photodetector. However, the immersion lens
provides better performance. The location of the photodetector and
the LED may be interchanged in any of the above described probes.
The bottom of any chamber formed in a base of an optical probe of
the present invention can remain exposed, be covered by a material
such as opaque tape, or be covered by a shell of base material
without affecting the reduction of motion artifacts brought about
by the chamber. Additionally, reflective measurements could be made
with the probes of the present invention by mounting both the
photodetector and LED on the base of the probe. Also, a plurality
of LEDs or photodetectors could be mounted in the chamber or
affixed to the material such that more than one signal may be
measured at a time. Furthermore, any material having a chamber,
with a detector or an LED mounted within the chamber, will reduce
the effects of motion artifacts in non-invasive absorption (or
reflection) measurements, according to the present invention.
FIGS. 29A-29B depict one embodiment of a disposable, optical probe
2002, and the attachment of the optical probe 2002 on the fingertip
2050 of an adult patient. As shown in FIGS. 29A-B, the disposable
optical probe 2002 is designed to fit comfortably onto a patient's
fingertip. Advantageously, the optical probe 2002 is also
configured to provide one or more of the following features: (i)
minimization of undesirable movement with respect to the tissue
under test (e.g., due to motion by the patient or contact of the
probe 2002 with an object or surface); (ii) minimization or
prevention of "light piping" (transmission) directly from the light
source (e.g., light emitting diode) to the detector (e.g.,
photodetector), (iii) minimization of the detector and LED
decoupling from the test site during motion, and (iv) the low noise
chamber configuration described above.
As illustrated in FIG. 29A, the probe 2002 includes a central
portion 2004, a pair of adhesive flanges 2005 extending from the
central portion 2004, a connector portion 2010 situated between the
flanges 2005, and a pair of smaller adhesive flaps 2015 extending
from the central portion 2004 on the end of the optical probe 2002
opposite from the connector 2010. The probe 2002 further includes a
connection aperture 2012 formed in the connector tab 2010, an
emitter aperture 2020 with an emitter (e.g., a light-emitting
diode) positioned within the central portion 2004 close to the
connector portion 2010. A flex pocket 2025 is located within the
central portion between the emitter aperture 2020 and a detector
aperture 2030 which allows light to pass through the detector
aperture 2030 to a detector assembly 2035. An adult fingertip 2050
is shown in phantom in FIG. 29A to illustrate the position at which
the fingertip 2050 would be placed when the probe 2002 is to be
fastened onto the fingertip 2050 for use.
Although not depicted specifically in FIGS. 29A-29B, the probe 2002
is fabricated from multiple layers, including a flex circuit layer,
a MYLAR (tm) layer, a face stock tape layer, and other tape layers,
depicted further in FIGS. 31-39.
FIG. 29B illustrates the probe 2002 fastened onto the fingertip
2050. As shown in FIG. 29B, the probe 2002 folds at the location of
the flex pocket 2025 over the fingertip 2050 such that the flex
pocket 2025 aligns with the very end of the fingertip and such that
adhesive flaps 2005 fold downward (in the illustration of FIG. 29B)
to wrap around the fingertip 2050 while the adhesive flaps 2015
fold upward (in the illustration of FIG. 29B) about a portion of
the circumference of the fingertip 2050 to provide support. As
shown in FIG. 29B, when the probe 2002 is folded about the
fingertip 2050, the emitter located within the probe is spaced
opposite the detector assembly 2035 such that light from the
emitter passes through the emitter aperture 2020, through the
finger 2050 and is incident upon the detector assembly 2035 through
the detector aperture 2030.
Advantageously, when the probe 2002 is attached to the finger, the
flex pocket 2025 is aligned at the tip of the finger 2050 so as to
provide alignment of the probe 2002 on the fingertip 2050. The flex
pocket 2025 also provides a highly flexible portion, thus providing
for reduced movement of the detector and LED assembly with respect
to the finger 2050 if the fingertip comes into contact with another
object. This provides a more stable probe with increased motion
resistance. In other words, the flex pocket also assists in
minimizing perturbations in the detected signal due to movement of
the detector and emitter with respect to the test tissue (e.g, the
finger). Furthermore, the flex pocket 2025 reduces light piping
since light is diverted around the circumference of the pocket.
In one embodiment, the flex pocket 2025 is formed to include an air
cushion or other cushion material to further absorb contact of the
probe 2002 with objects. In this manner, jarring of the probe 2002
in the event the fingertip 2050 moves slightly or in the event of
contact of the probe to another surface is minimized.
The probe 2002 includes an internal flex circuit 2051 which acts as
a spring-like shock absorber for the disposable probe. The flex
circuit 2051 also assists in reducing shifting between the emitter
2021 and the detector assembly 2035 due to contact or motion by the
patient. Thus, the internal flex circuit 2051, together with the
flex pocket 2025 act to minimize the decoupling of the detector
assembly.
FIG. 29B depicts a receiving connector portion 2060 which engages
with contacts 2052 on the connector 2010 to provide an electrical
connection between the optical probe 2002 and digital signal
processing circuitry (not shown in FIG. 29C). The digital signal
processing circuitry may be used to analyze the output of the
detector within the assembly 2035. In one advantageous embodiment,
the aperture 2012 catches onto a tab (not shown) within the
connector 2060 to firmly secure the connector 2060 with the optical
probe 2002. Once the optical probe 2002 is securely fastened to the
fingertip 2050 and the connector provides an electrical connection
between the optical probe 2002 and digital signal processing
circuitry, signals are detected from the detector 2035 and
transmitted to the processing circuitry via the connector 2060.
Further details of the receiving connector portion 2060 are
described in a patent application entitled "Patient Cable
Connector" filed on the same date as the present application and
assigned to the assignee of the present application, which
application is incorporated herein by reference as if fully set
forth.
FIG. 30 is a flow chart which illustrates the general steps in
accordance with the present invention to manufacture a first
embodiment of the disposable, optical probe 2002 depicted in FIGS.
29A-29C. A flex circuit is formed on a flex circuit panel as
represented by an activity block 3005. In one advantageous
embodiment, the flex circuit panel comprises a copper/MYLAR (tm) or
copper/CAPTON (tm) laminant, or, alternatively, is formed by
depositing a conductive ink on MYLAR (tm). For example, FIG. 31
depicts three etched flex circuits on a flexible circuit panel
material. The flex circuits have been formed by etching in one
preferred embodiment, and are comprised of one-ounce copper
(approximately 1.3 mils) over 1 mil of MYLAR (tm) or CAPTON
After the flex circuit has been etched in an appropriate copper
coated MYLAR (tm) substrate material, conductive pressure sensitive
adhesive (PSA) 2102 is applied to the end of the flex circuits
where the detector will be placed (hereinafter, the "detector
end"), as depicted in FIG. 31. After the conductive PSA (made by 3M
in the present embodiment, part No. 9703) is applied, a detector
component window 2104 is cut through the conductive PSA 2102 and
the flex circuit MYLAR (tm) base. An emitter component window 2106
is also cut through the flex circuit MYLAR (tm) base. A flex pocket
hole 2108 is also cut through the flexible circuit MYLAR (tm) base.
Next, detector shields 2110 are placed on the PSA at the end of the
detector end of the flex circuit, as depicted in FIG. 31A.
In one embodiment, the detector shields are etched copper shields
made of copper sheet. A grating 2111, which is about 80% open, is
etched through the shields to allow light from the light source
(e.g., LED) to transmit through the shield to a detector. The
resultant shield has a frame of approximately 4 mils thickness and
a grating of approximately 2 mils thickness. The shields provide a
Faraday Shield for the detector.
The diffraction grating aligns with the detector component window
2104 in the flex circuit and, when the probe is assembled, with the
detector aperture 2030 (FIG. 29A). The conductive PSA 2102 makes
electrical connection between a flex circuit ground trace 2112 and
the detector shield 2110 to connect the detector shield 2110 to
ground.
In one preferred embodiment, low temperature solder paste is
dispensed on contacts 2114, 2115, for the detector connections
(FIG. 31B), on contacts 2116, 2117 for the emitter connections and
on resistor pad 2118 for an identifying resistor. The emitter (LED)
2021, a detector 2120 and a resistor 2122 are placed and soldered
in the appropriate positions on the flex circuits as depicted in
FIG. 31B, and represented in an activity block 3010 (FIG. 30). The
solder operation is preferably performed through a direct heat
reflow of the low temperature solder. The emitter 2021 and detector
2120 are placed such that the transmission and detection field of
view are through the detector and emitter windows 2104 and 2106
(FIG. 31).
In one embodiment, the resistor 2122 advantageously is connected to
the ground trace on one end and a resistor signal trace 2113 at the
other end. In another embodiment, the resistor 2122 is connected in
parallel with the emitter 2021. The advantages of this parallel
connection are explained in detail in copending U.S. application
Ser. No. 08/478,493 entitled Manual and Automatic Probe
Calibration, which is incorporated herein by reference as if fully
set forth.
In one embodiment, the resistor 2122 provides a company identifier.
In other words, the resistor 2122 can provide a value that
specifically identifies that the probe is made by or for a
particular patient monitoring company. As explained in copending
U.S. application Ser. No. 08/478,493 the resistor can be read by
lowering the voltage across the LED to a point where the LED is
effectively off, thereby removing the LED from the circuit as a
current draw.
As mentioned above, and as seen in FIG. 31B, the flex circuit has
the aperture 2108 which is the aperture in the flex circuit forming
a portion of the flex pocket 2025 of the probe 2002. In addition to
the advantages of the high flexibility, this aperture 2108 through
the flex circuit prevents a direct line of transmission between the
emitter 2021 and the detector 2120. In other words, in use, light
from the emitter 2021 which reaches the detector 2130 should pass
through the medium under test (e.g., the finger or other tissue).
Direct transmission of stray light from the emitter directly to the
detector 2120 along a light conductive surface can cause erroneous
readings, especially during motion. This direct transmission of
light between the transmitter and detector is referred to herein as
"light piping." That is, if the probe between the emitter 2021 and
the detector 2120 has optical transmission properties, due to the
construction or the material of the probe, stray light from the
emitter may channel along the probe directly to the detector,
without passing through the tissue material under test. Light
piping is a heretofore unrecognized cause of noise and invalid
signals from such optical probes. The aperture 2108 minimizes or
prevents this "light piping" by preventing or minimizing a direct
line of transmission from the emitter 2021 to the detector 2120
along the flexible circuit. Thus, the aperture 2108 provides
benefits in the present invention of providing a highly flexible
portion of the flex circuit, which reduces decoupling of the LED
2021 and the detector 2120 during motion (due, for example, to
tapping on the finger tip), and preventing light piping between the
emitter and the detector.
Once the appropriate circuit elements are placed and soldered onto
the flex circuit, a flex circuit shield 2130, as depicted in FIG.
32A, is attached to the flex circuit panel as represented in an
activity block 3015. The placement of the flex circuit shield 2130
with the flex circuit is depicted in FIG. 32A and 32B. The flex
circuit shield 2130 is advantageously constructed from MYLAR (tm)
laminated with a thin conductive layer such as copper. In the
present embodiment, the laminated MYLAR (tm) is made by ACUTEK.
In the present embodiment, the flex circuit shield 2130 has an
insulator film 2132 depicted in double-cross hatching (made by
Coating Sciences, part number P-341 in the present embodiment), a
flex circuit shield conductive PSA strip 2133 (made by 3M, part no.
9703 in the present embodiment) and two non-conductive PSA strips
2134, 2135. As seen in FIG. 32A, the flex circuit shield 2130 has
an emitter aperture 2136, two flex pocket apertures 2137, and a
detector aperture 2138.
When the flex circuit shield 2130 is applied to the flex circuit,
the insulator strip 2132 insulates the signal traces of the flex
circuit from the metallization of the flex circuit shield 2130 to
prevent short circuits. As further depicted in FIGS. 32A and 32B,
when the flex circuit shield 2130 is positioned such that the
apertures align with corresponding apertures on the flex circuit,
the PSA strip 2135 provides bonding with the back of the flex
circuit, the conductive PSA strip 2133 provides for bonding of one
tab of the detector shield 2110 with the flex circuit shield 2130.
The conductive PSA strip 2133 also provides connection of the flex
circuit shield with the ground via the detector shield tab.
With the flex circuit shield in position, the flex circuit assembly
2132 (including the flex circuit, the emitter 2021, the detector
2120, the resistor 2122, and the shields 2110, 2130), are die-cut,
as depicted in FIG. 33A. The flex circuit shield 2130, along with
the detector shield 2110, is folded over the flex circuit as
represented in an activity block 3020. The final flex circuit
assembly 2051 is depicted in FIG. 33B.
Once folded, the insulator film 2132 prevents contact from the flex
circuit traces to the metallization in the flex circuit shield
2130. The PSA strip 2135 bonds the flex circuit shield to the
signal circuit side of the flex circuit. As depicted in FIG. 33B,
the contact fingers 2052 remain exposed.
As illustrated in FIG. 34, a base material 2140 also forms a layer
of the probe 2002. In one embodiment, the base material comprises
Avery 3044 base material. Each side of the base material is coated
with PSA adhesive (Coating Sciences, Inc., P-341 in the present
embodiment). The back side (in reference to the illustration of
FIG. 34) of the base material 214 is provided with the thin release
liner 2003 (see FIG. 29A, not shown in FIG. 34), preferably made
from a paper release liner or the like, as is well understood in
the art.
In the present embodiment, the base material is transparent to the
wavelength of the emitter 2021. The connector tab 2010 and an
optical cavity 2150, are placed onto a first adhesive side of the
base material 2140, as represented within an activity block 3025,
and depicted in FIG. 34. The connector tab 2010 is advantageously
formed of ABS styrene, and has the aperture 2012. The optical
cavity 2150 may, for example, have the configuration for its walls
in the shape of any of the above-disclosed bases (e.g., the bases
110, 1010, etc.) having a chamber formed therein. As depicted in
FIG. 34, the optical cavity has a rectangular receiving receptacle
2152 adapted to receive the detector end of the completed flex
circuit assemblies.
Additional detail of the optical cavity of the present embodiment
of the probe 2002 is depicted in FIG. 39A-39C. FIG. 39A depicts a
perspective view of the optical cavity 2150 for the probe 2002.
FIG. 39B depicts a bottom view of the optical cavity 2150 and FIG.
39C depicts a cross sectional view along 39C--39C of FIG. 39A. The
optical cavity 2150 is made from styrene in one embodiment. In one
preferred embodiment, the optical cavity is coated with an optical
coating that is opaque to ambient light. This can be on the inside
walls of the optical cavity or over the exterior walls of the
optical cavity, or the entire optical cavity can be coated. The
opaque coating advantageously prevents or minimizes the
transmission of ambient light from the surrounding environment
which could be incident on the detector if the optical cavity is
not opaque to ambient light. As an alternative to an opaque
coating, the optical cavity can be made from a material that is
opaque to ambient light.
Advantageously, the optical cavity 2150 has a wedge shape ramp 2154
as part of the rectangular receptacle 2152. As briefly mentioned
above, the rectangular receptacle 2152 is adapted to receive the
detector end of the flex circuit 2051. The wedge shaped ramp 2154
of the optical cavity 2150 provides a ramp for a smooth transition
for the flex circuit 2051 between the surface of the base material
to the rectangular receptacle table 2152.
Further illustrated in FIG. 40A are two side walls 2156 that runs
along the side border of the rectangular receptacle 2152 and an end
wall 2157 that runs between the two side walls 2156. These walls
hold the flex circuit 2051 in position such that the detector 2120
aligns properly with an aperture 2158 in the optical cavity.
Preferably, the flex circuit fits snugly between the side walls
2156 and against the end wall 2157.
In a preferred embodiment, the aperture 2158 has the configuration
of the cavities describe above (e.g., cones-shaped, cylindrical in
shape, or conical in shape, etc.).
Preferably, the PSA on the first adhesive side (FIG. 34) of the
base material 2140 allows simple attachment of the optical cavity
2150 and the connector tab 2010 through the application of
pressure.
After the connector tab 2010 and the optical cavity 2150 have been
placed on the base material 2140, the flex circuit assembly 2051 is
placed on top of the base material 2140, the connector tab 2010 and
the optical cavity 2150 as depicted in FIG. 35 on one end. The
detector end 2141 of the completed flex circuit assembly 2051 seats
within the rectangular receptacle 2152 of the optical cavity 2150,
as depicted in FIG. 35. Mounting of the completed flex circuit
assemblies 2051 is represented in an activity block 3030 (FIG.
30).
With the detector end 2141 of the flex circuit assembly 2051 seated
in the receptacle 2152 of the optical cavity 2150, the
photodetector mounted to the flex circuit assembly 2151 is
positioned to aligned with the aperture 2158 of the optical cavity
2150. In one embodiment, a hole, corresponding to the emitter
aperture 2020 and the detector aperture 2030, is cut in the base
material to correspond to the emitter 2021 and the detector 2120.
However, in the present embodiment, the base material is
transparent to the wavelength of the emitter 2021; therefore, holes
are not provided through the base material 2140 for the detector
and emitters.
As explained above in general, one of the advantages of the optical
cavity 2150 is that fleshy tissue can enter the cavity without
significant perturbation in the area of the field of view of the
detector. Even if no hole is cut in the base material, if the base
material chosen is very flexible, perturbation of the fleshy tissue
in the field of view of the detector 2100 will be minimal due to
the optical cavity aperture 2158, with the added benefit of not
creating optical geometrical changes if the base material is not
removed over the cavity.
A cover 2160 is placed over the optical cavity 2150 as represented
in an activity block 3035, and shown in FIG. 36. The cover is
advantageously a vacuum formed, cup-shaped cover. In the present
embodiment, the cover is made from polypropylene. In one
advantageous embodiment, the cover is opaque to ambient light. The
opaque characteristic can be obtained from a coating or from the
material of construction. The cover has flange 2162 which serves as
a bonding surface with the base material. Advantageously, PSA on
the base material provides the appropriate bond between the flange
2162 of the cover and the base material 2140.
A face stock 2170, advantageously constructed from a non-woven,
flexible material, is placed over the base material 2140. In an
alternative embodiment, a woven, flexible material is acceptable.
In the present embodiment, the face stock 2170 comprises 3M part
no. 9908. The face stock preferably has an aperture 2171 to allow
the cup portion of the cover 2160 to protrude through the face
stock. The face stock 2170 covers the flange portion 2162 (shown in
dotted lines in FIG. 37) of the cover 2160. This assists in holding
the cover 2160 firmly in place. Because the base material has PSA
on the side to which the face stock is applied, pressure applied to
the face stock bonds the face stock with the base material. In the
present embodiment, the face stock 2170 also has PSA on one side
(side down in FIG. 37). The face stock is cut such that the
connector tab 2010 and the connector traces 2052 of the flex
circuit remain exposed. This manufacturing step is represented in
an activity block 3040 and is depicted in FIG. 37.
In addition, to a cutout 2172 in the face stock 2170 and the base
material 2140 provide a slot on each side of the connector tab 2010
and the connection traces end of the flex circuit assembly 2051.
These slots are adapted to receive walls of the connector
receptacle 2060 (see FIG. 29B) for stability.
Finally, the optical probe is die-cut to a final shape as depicted
in FIG. 38 and represented in an activity block 3045 (FIG. 30). The
manufacturing method is complete, as represented within an activity
block 3055. Removal of the release liner 2003 on the base material
2140 allows for placement on the digit of a pediatric or adult
patient as depicted in FIGS. 29A-29B.
Another embodiment of a low noise optical probe 2200 is depicted in
FIG. 40A. This embodiment is advantageous for use with neonates, as
will be further described below. FIG. 41 is a flow chart which
details the general method used for manufacturing a neonatal
disposable optical probe 2200 in accordance with this second
embodiment of the present invention.
As with the previous embodiment, the neonatal probe 2200 is
constructed of several layers. A first tape layer 2210 is laid out
as represented in an activity block 4010, and depicted in FIG. 42.
Advantageously, the first tape layer 2210 is constructed from
release liner material. The first tape layer 2210 has adhesive
portions on one side for adhesion to the tissue material under
test, as will be further understood below. In the present
embodiment, the release liner is a conventional paper type release
liner for the medical industry.
In a preferred embodiment, the first tape layer 2210 has a first
portion of adhesive 2212 and a second portion of adhesive 2213
which provide adhesion in the area of the detector and emitters. In
the present embodiment, the adhesive portions 2212, 2213 are made
from 3M part number MED 3044, which is a medical quality two-sided
PSA material. This material is transparent to the wavelength of the
emitter in the probe 2200, and therefore, a thru hole is not
required. However, a thru hole, such as the thru hole 2211 could be
provided in one embodiment.
A second tape layer 2220 is placed over the first tape layer as
represented in an activity block 4020, and depicted in FIG. 43. The
second tape layer 2220 includes an emitter aperture (thru hole)
2222 and a detector aperture 2224, which provide windows for the
detector and emitters. In the present embodiment, the second tape
layer is made from a non-woven face stock material, with PSA on one
side. In the present embodiment, the second tape layer 2220
comprises part number 9908, made by 3M. In the illustration of FIG.
43, the adhesive side is up.
An optical cavity 2240 is placed onto the second tape as shown in
FIG. 43 and represented in an activity block 4030. One preferred
embodiment of the optical cavity 2240 is illustrated in additional
detail in FIGS. 44A-C. FIG. 44A depicts a perspective view of the
optical cavity 2240. FIG. 44B depicts a bottom plan view of the
optical cavity 2240, and FIG. 44C depicts a side cross-sectional
view through 44C--44C of FIG. 44A. As with the embodiment of FIG.
39A-C, the optical cavity 2240 is made from styrene or ABS or the
like in one embodiment. In one preferred embodiment, the optical
cavity 2140 is coated with an optical coating that is opaque to
ambient light. This can be on the inside walls of the optical
cavity or over the exterior walls of the optical cavity, or the
entire optical cavity can be coated. The opaque coating
advantageously prevents or minimizes the transmission of ambient
light from the surrounding environment which could be incident on
the detector if the optical cavity is not opaque to ambient light.
As an alternative to an opaque coating, the optical cavity can be
made from a material that is opaque to ambient light.
Advantageously, the optical cavity 2240 has a wedge-shaped ramp
2242 as part of a rectangular receptacle 2244. The rectangular
receptacle 2244 is adapted to receive the detector end of a flex
circuit, as further explained below. The wedge-shaped ramp 2242 of
the optical cavity 2240 provides a ramp for a smooth transition for
the flex circuit between the surface of the second tape layer 2220
to a rectangular receptacle table 2246.
Further illustrated in FIG. 44A are two side walls 2248 that extend
along the side border of the rectangular receptacle 2244 and an
arcuate end wall 2250 that extends between the two side walls 2248.
These walls hold the flex circuit in position such that the
detector aligns properly with a aperture 2252 in the optical cavity
2240. Preferably, the flex circuit fits snugly between the side
walls 2248.
In a preferred embodiment, the aperture 2252 has the configuration
of the cavities describe above in general (e.g., cone-shaped,
cylindrical in shape, conical in shape, etc.) A flex circuit 2254
is depicted in detail in FIGS. 45A-B. As depicted in FIG. 45A, a
flex circuit is formed on a flexible substrate 2255. In the present
embodiment, the flexible substrate advantageously comprises 3 Mil
polyester (e.g., MYLAR (tm)) with copper coating on 1 side. In the
present embodiment, the copper coating is 1/2 OZ. copper coating.
The circuit pattern is etched such that the circuit traces of
copper remain on a signal side of the flex circuit 2254 after
etching. From this etching standpoint, the flex circuit 2254 is
made in the same fashion as the flex circuit assembly 2051 of the
adult probe 2002.
Once the circuit is etched, it is placed on a bottom shielding
layer 2256, depicted in FIG. 45A. In one embodiment, the shielding
comprises a metallized MYLAR (tm) shield, with one side metallized.
The metallic side is positioned against the back side of the flex
circuit substrate 2255. Conductive PSA bonds the flex circuit
substrate 2252 with the bottom shielding layer 2256 through
connection 2251 connects the bottom shield metallization to ground
from the ground trace 2253. The bottom shielding layer 2256 has an
emitter aperture corresponding to the emitter aperture 2252 in the
optical cavity 2240 and the emitter aperture 2257 in the flex
circuit 2254. The bottom shielding layer 2256 extends (extension
labelled 2258 in FIG. 45A) beyond the detector end of the flex
circuit 2250. In an alternative embodiment, the back side of the
flex circuit 2254 has a metal coating, such as copper. This
provides appropriate shielding. Thus, the first shielding layer
could be eliminated in an alternative embodiment.
A detector shield 2260, such as the detector shield 2110 of the
probe 2002 (FIG. 32), is bonded to the signal trace side of flex
circuit 2254, as depicted in FIG. 45B. Next, a detector 2272 is
placed using low temperature solder, as with the previous
embodiment, such that the detector field of view is through the
grating 2261 in the detector shield 2260. The detector shield 2260
is then folded over the detector in order to provide a Faraday
shield, as with the previous embodiment.
The extension 2258 of the first shielding layer 2256 is then folded
over and conductive PSA is used to bond the metallized side of the
bottom shielding layer 2256 to the detector shield 2260. This
connects the detector shield to ground. The emitter 2270 is also
placed using the low temperature solder.
In one advantageous embodiment, a resistor 2262 is also placed
either in parallel with the emitter or is provided with its own
connection trace. The embodiment of FIG. 45A depicts an embodiment
with a separate connection trace 2263 for the resistor 2262.
A top shielding layer 2268 is placed to shield the signal side of
the flex circuit, as depicted in FIG. 45C. In the present
embodiment, this second shielding layer 2268 comprises the same
material as the first shielding layer 2256. The second shielding
layer 2268 is bonded to the detector shield 2260 using conductive
PSA which couples the second shielding layer 2268 to ground. The
second shielding layer 2268 covers the entire flex circuit and is
bonded to the flex circuit 2254 using PSA.
The flex circuit assembly 2254 of FIG. 45 used in the neonatal
probe 2200 is constructed with a unique V-configuration. The
emitter 2270 is at the tip of one branch, a detector 2272 is at the
tip of the other branch, and a connector tab 2274 (substantially
the same as the connector tab 2010) is attached at the base of the
"V."
The optical cavity 2240 is substantially the same as the optical
cavity 2150. In addition, the detector 2272 and the emitter 2270
are substantially the same as the detector 2120 and the emitter
2021.
Once the shielded flex circuit assembly 2254 is completed, the
completed flex circuit assembly is placed onto the second tape
2220, as depicted in if FIG. 46. The flex circuit 2250 is
positioned such that the emitter 2270 and the detector 2272 have a
field of view through the respective apertures 2222, 2224 in the
second tape layer 2220.
Once the flex circuit assembly is placed, third and fourth layers
of tape 2280, 2290 are placed over the flex circuit assembly 2254
as represented within an activity block 4040 and depicted in FIG.
47. The third and fourth tape layers 2280, 2290 are made from the
non-woven face material such as that made by 3M as part number
9908. The third and fourth tape layers 2280, 2290 have PSA on the
side which bonds to the assembly made up of the first tape layer
2210, the second tape layer 2220 and the flex circuit assembly
2254. As depicted in FIG. 47, the fourth tape layer 2290 is
configured to allow connection traces 2292 of the flex circuit to
remain exposed.
Finally, the neonatal disposable probe 2200 is die-cut to a final
shape as represented within activity block 4050 and depicted in
FIG. 48. The manufacturing method is then complete as represented
within an activity block 4060.
FIGS. 40A and 40B illustrate the neonatal probe being attached to a
baby's foot (shown in phantom). The finger is placed on the
detector branch of the probe 2200. The emitter branch is then
positioned so that the emitter 2270 is directly above the detector
2272 with the foot in-between. An adhesive strap 2400 (which was
die-cut from the first tape layer 2210 and the third tape layer
2280) is then wrapped around the foot to secure the relative
position of the emitter 2270 and detector 2272. It should be
appreciated that the adhesive material selected to coat the
adhesive strap should not be so strong as to tear or bruise the
skin of a newborn baby. The connector 2060 subsequently establishes
electrical connection between the probe 2200 and digital signal
processing circuitry via the connector tab 2294.
The unique V-configuration of the neonatal probe embodiment of the
present invention (e.g., as displayed in FIG. 49) is particularly
advantageous for use in applications where the optical probe is
used on neonates. The V-configuration allows the probe to be used
on many different sizes of monitoring sites (e.g., feet, hands,
etc.) for a neonate. With conventional wrap-around embodiments, the
spacing of the detector and emitter is fixed, thus making the use
of the probe for different sized monitoring sites more difficult.
In addition, the V-shaped design allows for the use of the probe on
various body parts. For instance, the probe 2200 could be attached
to the nose or ear of the neonate. The probe 2200 could also be
used as a reflectance probe with the probe attached to the forehead
of the neonate, or other relatively flat skin surface. Thus, the
V-design provides for the adaptation of the probe for many
different places on the neonate body.
An alternative embodiment of the V-configuration is depicted in
FIG. 49. In the embodiment depicted in FIG. 49, the adhesive
extension 2400 (FIG. 48) is not provided. In this embodiment, the
probe can be used with conventional medical tape or the like, or
can be provided such that the adhesive 2212, 2213 (FIG. 42) in the
area of the detector and emitter hold the probe in place.
Alternatively, a soft, spongy, hospital wrap (e.g., a POSEY wrap)
2498 can be configured to firmly hold the probe to a digit as
depicted in FIG. 50.
Another embodiment of the method of making the neonatal probe is
illustrated in FIGS. 51-55. An X-ray type view of the alternative
embodiment 2500 is depicted in FIG. 51. As illustrated in FIG. 51,
the probe 2500 has a detector 2502, an emitter 2504, a flex circuit
2506, a low noise cavity 2508 and a cover 2510 for the optical
cavity 2508, top and base tapes 2512, 2514, an identification
resistor 2516, thru connections 2518, 2520, and a connection tab
2522. This embodiment of the probe is depicted without the tape
extension, such as the extension 2400 (FIG. 48), but could include
a tape extension in one embodiment. The overall configuration of
the finished probe 2500 is nearly identical to the probe of FIG.
49. However, the shielding is different, the optical cavity has a
cover, and the probe 2500 is constructed using two tapes instead of
four. The construction of this embodiment of the probe 2500 is
similar to the adult probe from the standpoint of the tape-up.
FIGS. 52A and 52B illustrate a base tape 2530 and the top tape
2540. The base tape 2530 has a detector component window 2532 and
an emitter component window 2534. Advantageously, the component
windows form apertures through the base tape 2530. Therefore, in
one preferred embodiment, clear (i.e., transparent to the emitter
wavelengths) window material portions 2536, 2538 are provided as a
cover to the component windows 2532, 2534. In one embodiment, the
clear window material is made from the 3M, Med 3044 described
above. The MED 3044 is attached to the back-side (with reference to
the illustration in FIG. 52A) of the base tape 2530 in order to
provide adhesion to the tissue material under test. Alternatively,
the window material 2536, 2538 is non-adhesive, and can be mounted
to the up-side (with reference to the illustration in FIG. 53A) of
the base tape.
In the present embodiment, the base tape 2530 is formed of a
laminate formed of a first layer of non-woven face stock, such as
that made by 3M as part number 9908, and a second film, such as
single-sided PSA film sold by Coating Sciences, Inc. as P-341. The
face stock has PSA on one side. In the illustration of FIG. 52A,
the PSA for the face stock is up. The second film of material is
laminated to the first layer of non-woven face stock. In the
present embodiment, the second layer also has one side with PSA. In
the illustration of FIG. 52A, the PSA side of the second film is
up. Accordingly, the side of the base tape 2530 depicted in FIG.
52A has PSA from the second film. In the present embodiment, the
second film comprises a 1 Mil layer of Coating Sciences part number
P-341. The use of two layers provides improved isolation to the
flex circuit.
FIG. 52B illustrates the top tape 2540, which is also formed of the
two layers of material as with the base tape. In the illustration
of FIG. 52B, the adhesive side of the top tape is down and the face
stock side of the top tape 2540 is up. For the present embodiment,
the top tape has a cutout 2542 for the cover 2510 to the optical
cavity 2508. The optical cavity 2508 has the same configuration as
the optical cavity 2240 FIG. 44.
An appropriate cover 2510 is depicted in detail in FIG. 55A-C. The
cover is cup-shaped to fit snugly about the optical cavity 2508.
FIG. 55A depicts a top view of the optical cover 2510. FIG. 55B
depicts a side cross sectional view through B-B in FIG. 55A. FIG.
55C depicts an end cross-sectional view through 55C-55C in FIG.
55A. In the present embodiment, the cover 2510 is vacuum formed
from styrene, and is coated with a light absorbing paint, such as
black paint to reduce the effects of ambient light.
FIGS. 53A illustrates the signal side of an appropriate flex
circuit 2506 and FIG. 53B illustrates the back side (i.e., shield
side in the this embodiment) of the flex circuit 2506. As depicted
in FIG. 54B, the signal side of the flex circuit 2506 has signal
traces, the identification resistor 2516, and the two through
connections 2518, 2520. The flex circuit also has connection pads
2560, 2562 for the detector 2502 and connection pads 2564, 2556 for
the emitter 2504. As with the previous embodiments, the signal side
of the flex circuit 2506 has traces formed by etching away the
metallic coating. The flex circuit is formed of the same materials
as described for the previous embodiments of flex circuits.
FIG. 53B depicts the shield side of the flex circuit 2506. In this
embodiment, the flex circuit 2506 is a two-sided circuit, with the
shield side coated, substantially in its entirety, with metal, such
as copper. By providing a metallic shield side, a separate
shielding layer is not needed for the back of the flex circuit
2506. The through connections 2518, 2520 connect the shield side
metal to the ground trace 2510.
FIG. 54 illustrates a top shield 2570 for the flex circuit 2506. In
the present embodiment, the top shield 2570 is formed from a
metallized MYLAR (tm), as with the shields for the previous
embodiment. Prior to application of the top shield 2570, the
detector 2502 and the emitter 2504 are soldered to the connection
pads 2560, 2562, 2564, 2566. Then one end of a detector shield
2572, having the same configuration as the detector shield 2260
(FIG. 45B) is connected to the shield side of the flex circuit
2506. In one embodiment, the connection is made with solder or
conductive PSA.
The top shield 2570 is applied to the signal side of the flex
circuit 2506 (with the non-metallized side against the signal side
of the flex circuit) with PSA. The detector branch 2574 of the top
shield 2570 is longer than a detector branch 2563 of the flex
circuit 2506. Thus, the detector branch 2574 is positioned such
that the end of the detector branch 2574 covers the detector 2502.
Conductive PSA 2576 is applied to the end of the metallized side of
the detector branch 2574. The detector shield 2272 is folded over
the top shield 2570 and connection is made via the conductive PSA
2576. In this manner, top shield 2570 is coupled to ground via the
connection detector shield 2572 which is connected to ground via
its connection to the shield side of the flex circuit 2506.
Once the flex circuit assembly 2506 is completed, it is placed on
the base tape 2530, with the detector 2502 and the emitter 2504
aligned with the detector window 2532 and the emitter window 2534,
respectively. The detector 2502 also is positioned in the
rectangular receptacle table of the optical cavity 2508. The
optical cavity cover 2510 is then placed over the optical cavity
2508. Finally, the top tape 2540 is placed over the entire assembly
with the cut-out for the optical cavity cover aligned with the
cover 2510. The entire assembly is pressed to set the PSA adhesive
on the base tape 2530 and the top tape 2540. The assembly is then
die cut to the shape depicted in FIG. 51.
This embodiment of the probe 2506 has the advantage of fewer
assembly steps, and therefore reduced cost. The use of the cover
2510 also allows for further isolation of the detector from ambient
light. As discussed above, the cover, as well as the optical
cavity, can be made opaque to ambient light, either through
coatings or pigmented or otherwise impregnated materials.
In accordance with another embodiment of the invention, a reusable,
low-noise, optical probe 2300 is constructed as depicted in FIG.
56. The probe 2300 comprises a padded, clip-on bracket 2305 which
comfortably secures the probe 2300 onto a patient's fingertip (not
shown in FIG. 56). The probe further includes a detector 2310
(shown in phantom) which detects optical radiation emitted by an
emitter 2320 (also shown in phantom). An aperture 2330, which is
substantially similar to the aperture 1020, is formed in the probe
2300 to provide the advantages enumerated above with respect to the
aperture 1020. Power to activate the LED 2320, is provided via a
connector cable 2340. The cable 2340 also provides a return path
for signals output by the detector 2310. Advantageously, the
reusable probe 2300 can have a connector with a similar
configuration as the connector for the disposable probes, such that
the instrument connector can be the same for use with disposable
and reusable probes.
The probe of the present invention may be employed in any
circumstance where a measurement of transmitted or reflected energy
is to be made, including but not limited to measurements taken on a
finger, an earlobe, a lip, or a forehead. Thus, there are numerous
other embodiments including, but not limited to, changes in the
shape of the probe, changes in the materials out of which the probe
is made including rigid and resilient materials, and changes in the
shape, dimensions, and location of the chamber. Moreover, the
chamber(s) may be coated, in whole or in part, with reflective
material to help direct energy onto the detector. Furthermore, the
probe of the present invention may be employed in measurements of
other types of energy. Depending upon the type of energy which is
most advantageously utilized in a measurement, the type of
transmitter or receiver of energy may be changed. The invention may
be embodied in other specific forms without departing from its
spirit or essential characteristics. The described embodiments are
to be considered in all respects only as illustrative and not
restrictive. The scope of the invention is, therefore, indicated by
the appended claims rather than by the foregoing description. All
changes which come within the meaning and range of equivalency of
the claims are to be embraced within their scope.
* * * * *